Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- Dynamic Mixing Tips EUDAMEDDynamic Mixing Tips P12 FDA UDI
- Model / Reference
- TF-312 (HS) EUDAMED5720912 EUDAMEDFDA UDI
- Description
- Dynamic Mixing Tips P12 FDA UDI
Identifiers
- Catalog Number
- 5720912 FDA UDI
- Primary DI / UDI-DI
- 10304040095697 EUDAMEDFDA UDI
- Basic UDI-DI
- 03040431201BK EUDAMED
- Unit of Use DI
- 00304040095690 EUDAMED
- FDA Product Code
- JDZ FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material mixing nozzle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4210 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
Yes
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 | 03040431201BK | 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 77c95e31-3ceb-4e96-99d2-7f5976e32920 61 fields · synced Jul 9, 2026
- FDA UDI 59e773d4-1693-4d5a-b3b1-5a520a39e8e0 34 fields · synced May 30, 2026