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Henry Schein
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9000733Model TF-257 (HS)Ref 9881929Model TF-123Ref 1008658Model TF- 118 (HS)Ref 9006231
Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDIImage Tooth Shade Acrylic FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDIPreformed dental crown, temporary FDA UDI
- Device Name
- Dental Articulating Paper EUDAMEDRotary NiTi file U Coro CX orange 19mm EUDAMEDPolycarbonate Crown EUDAMEDImage Tooth Shade Acrylic FDA UDIPolycarbonate Crowns FDA UDI
- Model / Reference
- TF-257 (HS) EUDAMED9000733 EUDAMED1008658 EUDAMEDFDA UDITF-123 EUDAMED9881929 EUDAMEDTF- 118 (HS) EUDAMED9006231 EUDAMED2282600 FDA UDI
- Description
- Image Tooth Shade Acrylic FDA UDIPolycarbonate Crowns FDA UDI
Identifiers
- Catalog Number
- 2282600 FDA UDI1008658 FDA UDI
- Primary DI / UDI-DI
- 10304040095383 EUDAMED10304040055523 EUDAMEDFDA UDI10304040131173 EUDAMED10304040097844 EUDAMED00304040001165 FDA UDI
- Basic UDI-DI
- 03040425701CV EUDAMEDB-10304040131173 EUDAMEDB-10304040055523 EUDAMEDB-10304040097844 EUDAMED
- Unit of Use DI
- 00304040095386 EUDAMED
- FDA Product Code
- EBG FDA UDIELZ FDA UDI
- EMDN Code
- Q01020201 ARTICULATION PAPERS EUDAMEDQ010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMEDQ01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Temporary dental crown/bridge resin FDA UDIPreformed dental crown, temporary FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI872.3330 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMEDEUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Dimensions & Sizes
- Size
- Weight — 125 Gram FDA UDI
Henry Schein by Henry Schein, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 03040425701CV | Class I | Active |
| EUDAMED | European Union | CE/MDR | 03040425701CV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein Inc.
- EUDAMED SRN
- US-MF-000021683
- Authorised Representative
- Henry Schein Services GmbH DE-AR-000008001
Sources (6)
- EUDAMED de36d1a7-f1d8-4537-9b10-96c9ef877026 61 fields · synced Oct 1, 2026
- FDA UDI 6ecb874d-57ff-4b45-959a-8fcd7f8f539e 36 fields · synced May 25, 2026
- FDA UDI 78519525-33d9-4974-be01-a1f100a63b1a 34 fields · synced May 30, 2026
- EUDAMED 1bf1fd9b-3ccc-4a44-bfaf-778ed5830835 61 fields · synced Jun 20, 2026
- EUDAMED 5b081d1b-9693-4c82-9f98-471720bf70cc 61 fields · synced Jul 16, 2026
- EUDAMED a421565e-7df0-4aa1-9433-a99c531b46a4 61 fields · synced Oct 1, 2026