Brackets PDF To LandingTo Landing
Packaging Concept Proposal 2026

SLX
Bracket Packaging

Paper-based · Nachhaltig · MDR-konform · Skalierbar auf 6 Millionen Einheiten. With integrated digital IFU via GS1 QR code — for Henry Schein Orthodontics.

6M
Units / Jahr
3
Varianten
8
Sprachen QR
0
Plastik Outer
HENRY SCHEINORTHODONTICS
SLX Metal
Stainless Steel 316L · 20 Brackets
BACK PANEL
REF · LOT · EXP · BARCODE · QR
HS
↔ Ziehen zum Drehen · 118 × 58 × 10 mm
♻️
100% PaperKein Plastik-Outer
🔗
GS1 Digital LinkISO/IEC 18975 QR
🏥
MDR 2017/745Class I Compliant
📈
6M Units/Jahr0,75 EUR/Box @ 6M
🌐
8 LanguagesDynamische IFU URL
Technical Innovation

The technology
behind the box._

Diese Verpackung ist kein Container — sie ist ein integriertes klinisches Kommunikationssystem. Jede Designentscheidung dient einem technischen oder regulatorischen Zweck.

01
🔗
GS1 Digital Link
QR Architecture
The QR code encodes a complete GS1 Digital Link (ISO/IEC 18975) carrying UDI-DI, lot number, expiry date and language detection. One QR replaces the entire multilingual leaflet.
ISO/IEC 18975GS1 Digital Link Standard
02
♻️
Zero-Plastic
Paper Engineering
Outer box and inner tray are paper-based: 350gsm SBB-board and molded pulp. No plastic film, no thermoformed shell. 100% recyclable through standard paper waste streams.
100% PaperOuter + Tray, FSC-certified
03
🎨
Color-Coded
SKU System
Metal / Ceramic / Clear share the same die-line, but are differentiated by three color-coding systems on header and accents. Chair-side identification is instant.
3 VariantsOne die-line · zero mix-ups
04
🏥
MDR 2017/745
Compliance by Design
All mandatory symbols (ISO 15223-1:2021), UDI carrier, multilingual requirements and labeling fields are integrated into the die-line from day one — not retrofitted.
Class I MDREU 2017/745 · Technical file ready
05
🔒
Molded Pulp
Precision Tray
20 brackets in individually embossed cavities — labeled UR/UL/LR/LL and positions 1–5. No loose brackets, no mix-ups. Molded pulp is inert and suitable for cleanroom handling.
20-Slot TrayEmbossed position labels · No plastic
06
📈
6M Units
Production Scale
Sheet-fed offset + molded pulp tray is the optimal combination for 500k–10M units/year. Unit cost at 6 M: 0.75 EUR. Reorder lead-time: 2–3 weeks.
0,75 EURPer unit at 6M volume
Material
350 gsm SBB
GC2 coated · Gloss UV + Spot UV
Print
Offset CMYK + PMS 116C
Gold: PMS 116C or hot foil stamping
Format
118 × 58 × 10 mm
Lid-and-base style · Molded pulp tray
Capacity
20 Brackets / Box
10 Upper + 10 Lower · 5L+5R per jaw
Interactive 3D · Three.js WebGL · REV 02

Photorealistic Rendering — Closed & Open State

Real-time WebGL with physically-based lighting, soft shadows and PBR materials. Switch variant, open lid, peel the protective film — or export as PNG for the print master.

Loading 3D rendering…
Three.js · WebGL · ~2 Sek
0%
Outside Views · Technical

Closed Box — Outside Layouts

Scaled outside views with dimensions. Brand on TOP, Anti-Slip-Base on BOTTOM, LOT/REF/EXP/UDI on the side strips.

TOP · Outside

SLX-TOP-118x58
118 MM 58 MM HENRY SCHEIN ORTHODONTICS PROFESSIONAL SLX Variant 20 pcs · Stainless · Ceramic · Clear REF · HS-SLX-{MET|CER|CLR}-20

BOTTOM · Outside (Anti-Slip)

SLX-BOT-118x58
118 MM HENRY SCHEIN ORTHODONTICS · IFU / REGULATORY ANTI-SLIP SILICONE peel protective film before first use ▸ PEEL OFF PET film, 50 µm silicone adhesive · zero residue silicone pad 108 × 50 × 1.2 mm · PSA · ASTM D903 peel ≥ 8 N/25mm

SIDE · Long Edge (Lid)

SLX-SIDE-118x10
118 MM 10 MM HENRY SCHEIN ORTHODONTICS SLX · REF HS-SLX-XXX-20

SIDE · LOT / EXP / UDI

SLX-SIDE-LOT
LOT NN0000-00 EXP YYYY-MM · UDI (01)0760xxxxxxxxx 118 MM × 10 MM
Inside Views · Technical

Opened Box — Inside Layouts

Inside lid with FDI position map, EVA foam tray with 20 bracket cavities in 4 quadrants (UR / UL / LR / LL), cardboard base with foam cutouts and section view with complete layer stack-up.

INSIDE LID · Position Map FDI

SLX-LID-FDI
BRACKET POSITION MAP · FDI NUMBERING UPPER LOWER UR5UR4UR3UR2UR1 UL1UL2UL3UL4UL5 LR5LR4LR3LR2LR1 LL1LL2LL3LL4LL5 20 brackets · FDI quadrant numbering · matches foam cavities 1:1

BASE · Over EVA Foam

SLX-BASE-FOAM-TOP
UR UL LR LL EVA foam 3 mm · die-cut · 20 cavities · 4 quadrants

BASE · Cardboard Substrate

SLX-BASE-SUB
IFU POCKET 350 gsm folding carton · die-cut foam mounts · IFU recess 30 × 90 mm

SECTION · Layer Stack-Up

SLX-SECT-FRT
118 MM 10 MM LID · 4.5 mm BASE · 5.5 mm EVA FOAM 3 mm — 20 cavities ANTI-SLIP SILICONE PAD · 1.2 mm PET PROTECTIVE FILM 50 µm — PEEL BEFORE USE Lid (cardboard) EVA foam tray Silicone anti-slip Peel-off PET film stack-up: lid · brackets · foam · cardboard · silicone · film
Feature · New in REV 02

Anti-Slip Silicone Base with peelable protective film

To prevent the package from sliding on the work bench, a 1.2 mm medical-grade silicone anti-slip base bonds to the underside — covered by a residue-free PET protective film for shipping. Peel off before use.

HENRY SCHEIN · LID 350 gsm SBB BASE + EVA FOAM TRAY · 20 BRACKETS SILICONE ADHESIVE LAYER · pressure-sensitive · 0.2 mm SILICONE ANTI-SLIP PAD · 1.2 mm · Shore A 40 ▸ PEEL OFF silicone adhesive · zero residue PET PROTECTIVE FILM · 50 µm — remove before first use
  • 1

    Medical silicone instead of PUR foam

    Silicone pad Shore A 40, 1.2 mm — high friction coefficient on stainless steel, glass, laminate. Package stays fixed on the treatment tray even during single-handed operation.

  • 2

    Residue-free silicone PSA

    Pressure-sensitive adhesive bonds to cardboard substrate, NOT to the PET film. Zero adhesive residue when peeled — tested per ASTM D6195 (peel) + ISO 2409 (residue).

  • 3

    PET protective film 50 µm, blue

    Blue-tinted film signals 'remove before use' instantly. Cornered pull-tab at 26° angle for single-handed peeling without tools.

  • 4

    Reusable adhesion, washable

    Silicone surface cleanable with isopropyl alcohol — adhesion restores. Package survives 50+ cleaning and placement cycles without losing grip.

  • 5

    Compliance & Materials

    USP Class VI silicone · ISO 10993-5 cytotoxicity · REACH/RoHS compliant. PET film LDPE-free, recyclable (code 1). Material data sheets included in delivery scope.

Product line

Three variants.
One system.

Identical format, identical die-cut tooling. Color-coded headers enable instant identification chairside.

Variant 01
SLX Metal
316L medical stainless steel
Standard full-arch cases
HENRY SCHEIN
SLX Metal
Material316L stainless steel
Slot0.022" × 0.028"
PrescriptionRoth / MBT
Header color■ HS Red #ED1C24
REFHS-SLX-M-01
Variant 02
SLX Ceramic
Polycrystalline alumina Al₂O₃
Aesthetic adult orthodontics
HENRY SCHEIN
SLX Ceramic
MaterialPolycrystalline Al₂O₃
Slot0.022" × 0.028"
PrescriptionMBT
Header color■ Dark red #C8102E
REFHS-SLX-C-01
Variant 03
SLX Clear
Ultra-clear polycarbonate PC
Maximum aesthetic requirements
HENRY SCHEIN
SLX Clear
MaterialMedizinisches PC
Slot0.022" × 0.028"
PrescriptionRoth
Header color■ Ozeanblau #1A3A5C
REFHS-SLX-X-01
Commercial · Offer / Pricing Matrix

Volume Pricing — from Sample to 6M Units

Final-order price locked in for the Henry Schein 6 M unit volume commitment. The quote matrix below covers every MOQ tier and serves as the negotiation baseline for pilot tranches or variable call-off quantities.

Final Order · Henry Schein
0,75
EUR / unit · 6,000,000 units
Total Volume
6.000.000 pcs
Currency
EUR
Net Order Value
EUR 4.5M
Incoterm
FCA Suzhou

Volume Pricing Matrix · MOQ Tiers

USD / unit · ex works
10.000 pcs · Pilot
1,90 USD
100.000 pcs · Soft-Launch
1,50 USD
500.000 pcs · Series-1
1,20 USD
1.000.000 pcs · Annual Q1
0,90 USD
3.000.000 pcs · 6-Month Run
0,85 USD
6.000.000 pcs · Full-Year-Commit
0,75 USD
Included per unit:
  • 350 gsm SBB folding carton · CMYK + PMS 116C gold spot color
  • EVA foam tray, 3 mm, die-cut · 20 bracket cavities · IFU pocket
  • Silicone anti-slip base 108 × 50 × 1.2 mm · PET protective film with peel tab
  • GS1 barcode + UDI print · LOT + EXP variable print
  • Multilinguales IFU-Sheet (8 Languages)
Test QR target →
Digital Integration

Ein QR.
Eight languages.

The QR code on every box automatically resolves to the matching language version — based on device locale. Content can be updated without reprinting a single box.

🇬🇧 EN
🇩🇪 DE
🇫🇷 FR
🇮🇹 IT
🇪🇸 ES
🇵🇹 PT
🇵🇱 PL
🇨🇳 ZH
🔗
GS1 Digital Link (ISO 18975)UDI-DI + LOT + EXP in one QR — MDR 2017/745 compliant data carrier
🔄
Dynamic redirect architectureURL bleibt auf der Box fix — Backend routet zu aktualisierten Inhalten
📏
12 × 12 mm · Matt-Lack-FensterISO 18004 Level M Fehlerkorrektur · Scan ab 5 cm Entfernung · UV-stablee Tinte
Technische Specification

Full
Specification.

All dimensions, materials, print parameters and regulatory requirements in one document. Production-ready for ISO 9001-certified packaging partners.

01Format & Dimensions
Width (W)118 mm ± 0.5 mm
Height (H)58 mm ± 0.5 mm
Depth (D)10 mm ± 0.3 mm
Lid panel14 mm
Glue tab8 mm
Format typeSlide-open tuck-end carton
Inner TrayMolded pulp, 20-slot
Bracket-Capacity20 pcs (10 OK + 10 UK)
02Material & Substrate
Substrate350 gsm SBB / GC2 coated
Grammage tolerance± 10 gsm
Thickness (caliper)0.40 mm ± 0.02 mm
Brightness (ISO)≥ 85 CIE whiteness
Tray — Option A350–400 gsm molded pulp (preferred)
Tray — Option B0.25 mm APET clear (fallback)
AdhesiveWater-based hotmelt, pharma-grade
Ink complianceEuPIA GMP guidelines
03Print & Color
Print methodSheet-fed Offset CMYK
Spot color 1PMS 116C (gold strip)
Spot color 2PMS Red 032 (red — Ceramic)
Spot color 3PMS 288C (navy — Metal/Clear)
SurfaceGloss UV (all-over)
Spot UVLogo + product name
Registration± 0.2 mm all panels
Delta-E targetΔE ≤ 2.0 vs. brand standard (ISO 13655)
04Production & Volume
Annual volumeUp to 6,000,000 units
MOQ per SKU50,000 units
Unit cost (6M)0,75 EUR
Die-cut tolerance± 0.3 mm
Lead-time — first run4–6 weeks
Lead-time — reorder2–3 weeks
Master carton50 boxes per shipping unit
Delivery termsEXW supplier or FCA
05Regulatory Compliance — Overview
EU MDR 2017/745 Class INon-sterile, no measurement function — self-certification
ISO 15223-1:2021 SymbolsAll mandatory symbols integrated on back panel
UDI Carrier (GS1 DL)QR with UDI-DI + production code ISO/IEC 18975
MultilingualEN + DE + FR printed · 5 additional languages via QR
REACH / RoHSDeclaration of conformity required from ink and carton suppliers
Recyclability100% paperboard — recyclable in standard paper waste stream
06Project timeline · to be defined

Status: Project timeline and delivery dates will be confirmed in a follow-up alignment with Henry Schein, once the following open items are resolved:

  • ·Final bracket specifications (slot · material batch)
  • ·Off-take commitment (MOQ per quarter)
  • ·UDI / GS1 data model for QR + barcode print
  • ·Logistics requirements (hub-centralized vs direct-ship)
  • ·Language set for final IFU content (verify 8 languages)
  • ·Regulatory sign-off MDR / FDA notification

Indicative phases after contract signing · to be finalized with customer: Tooling 8-10 W → DOE Sampling 3-4 W → Pilot Run 10k 4 W → Soft-Launch 100k 6 W → Volume Ramp from month 6.

Technical Design

Build Guide
& Dieline.

This section is the interface between design and printer. All specifications match the final die-line and are production-ready.

Cut line Fold line Glue tab SCALE 1:1.8 · ALL DIMENSIONS IN MM
TUCK FLAP TUCK FLAP GLUE GLUE SIDE SIDE HENRY SCHEIN ORTHODONTICS SLX Metal Orthodontic Brackets · 20 pcs FRONT PANEL HENRY SCHEIN ORTHODONTICS BARCODE · GS1-128 · LOT + EXP + UDI ⚙ Hersteller 📅 Verw.-Datum 🔢 Lot 📖 IFU BACK PANEL TOP DEPTH TOP DEPTH LID FRONT LID BACK 118 mm 58 mm 10 14 mm
01
Prepare
sheet print
CMYK + PMS 116C on 350gsm SBB sheet. Print registration ± 0.2 mm. Gloss UV all-over, Spot UV on logo.
02
Die-cut &
crease
Flatbed die-cut per dieline. Tolerance ± 0.3 mm. Prepare all crease lines for clean fold.
03
Fold &
glue
Glue the side seam with pharma-grade water-based hotmelt. Erect the box form, apply the glue tab.
04
Insert
tray
Insert molded-pulp tray (20-slot) into box. Verify cavity alignment: UR/UL top, LR/LL bottom.
05
QC &
ship empty
Vision-check print + die geometry. Stamp lot + EXP on back panel. Pallet empty boxes ex works. Bracket filling happens at Henry Schein.
Material Specification — All Components
Outer Box
350gsm SBB
GC2-coated, ISO Coated v2 · Gloss UV + Spot UV logo
Inner Tray
Molded pulp 400gsm
Molded pulp, 20 cavities · FSC-certified
Adhesive
WB Hotmelt
Water-based, pharma-grade · solvent-free
QR-Code Ink
UV-stable
Matte varnish window 12×12mm · ISO 18004 Level M
Farbsystem — Printfarben & Sonderfarben
HS RotPMS Red 032 / #ED1C24
HS BlauPMS 288C / #003087
HS Blue AccentPMS 285C / #0072BC
HDH InkCMYK 90/70/40/90
Clear HdrPMS 2767C / #1A3A5C
Box BodyCMYK 2/2/3/0
Tolerance table — dimensional accuracy & quality control
Parameter Nominal Tolerance Test method Frequency Status
Box width118.0 mm± 0.5 mmCaliperEach palletPASS
Box height58.0 mm± 0.5 mmCaliperEach palletPASS
Box depth10.0 mm± 0.3 mmCaliperEach palletPASS
Print registration0.0 mm± 0.2 mmMicroscope / 10× loupeEach print sheetPASS
Carton grammage350 gsm± 10 gsmGrammage testerBatch inspectionPASS
Delta-E colorΔE = 0.0≤ 2.0SpectrophotometerEach makereadyPASS
QR-code scanSuccess100% read rateGS1-compliant scannerEach boxPASS
Tray fitTight±0 (no play)Manual / tactileSample 1:500PASS
Projektroadmap

From Idea
to Production.

Week 1-2
Concept sign-off
Design approval · HDH guideline integration · variant confirmation
Woche 2–4
Lieferanten RFQ
Produktionsbrief an 3–5 ISO-zertifizierte Verpackungspartner
Woche 4–6
Werkzeug & Artwork
Printdaten finalisieren · Stanzmesser + Papiermark-Form bestellen
Woche 6–8
Proof & Freigabe
Digital-Proof → Nass-Andruckbogen → Freigabe · QR-Seite live
Woche 8–10
Pilotlauf
500 Boxen je Variante · MDR-Technische-Akte-Muster inklusive
Ab Woche 10
Serienproduktion
Skalierung auf 6M Einheiten/Jahr · 3D-Webseite deployed