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TMS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 2 x 100 pcs
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T12
Identity
- Trade Name
- TMS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 2 x 100 pcs EUDAMEDTMS FDA UDI
- Generic Name
- Dental restoration retention pin FDA UDI
- Device Name
- TMS Pins EUDAMEDMINIM 2-in-1 Bulk Kit FDA UDI
- Model / Reference
- T12 EUDAMEDFDA UDI
- Description
- MINIM 2-in-1 Bulk Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661T121 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661T121 EUDAMED
- FDA Product Code
- EBL FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental restoration retention pin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3740 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
Moist Heat or Steam Sterilization FDA UDI
TMS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 2 x 100 pcs by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661T121 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED d3cb344e-60c8-4323-bbb5-bf055480203b 61 fields · synced Jul 22, 2026
- FDA UDI e28b1fea-c577-4252-a860-7918c70b26dd 33 fields · synced May 30, 2026