Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Dental mould FDA UDI
- Device Name
- Strip-Off Crown EUDAMEDStrip Crown Forms FDA UDI
- Model / Reference
- TF- 119 (HS) EUDAMED1006684 EUDAMEDFDA UDI
- Description
- Strip Crown Forms FDA UDI
Identifiers
- Catalog Number
- 1006684 FDA UDI
- Primary DI / UDI-DI
- 10304040055301 EUDAMEDFDA UDI
- Basic UDI-DI
- 03040411901BY EUDAMED
- Unit of Use DI
- 00304040055304 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental mould FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Henry Schein by Henry Schein, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 03040411901BY | 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 (2)
- EUDAMED d272fa9e-cedb-45a0-951c-c23b3d56b4bc 61 fields · synced Jul 27, 2026
- FDA UDI fca12f5a-a1c3-45f8-8a10-5f38cf432605 34 fields · synced May 30, 2026