TMS LINK PLUS Bulk Kit, Minim Silver, Titanium Alloy, 50 pcs
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- TMS LINK PLUS Bulk Kit, Minim Silver, Titanium Alloy, 50 pcs EUDAMEDTMS FDA UDI
- Generic Name
- Dental restoration retention pin FDA UDI
- Device Name
- TMS Link Plus EUDAMEDMINIM Single Shear Bulk Kit - Titanium FDA UDI
- Model / Reference
- L822 EUDAMEDFDA UDI
- Description
- MINIM Single Shear Bulk Kit - Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661L8221 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661L8221 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
TMS LINK PLUS Bulk Kit, Minim Silver, Titanium Alloy, 50 pcs by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661L8221 | 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 ad163c66-76d7-46a0-8d76-c7d4c60b2121 61 fields · synced Jun 18, 2026
- FDA UDI 94b2109c-83a2-4a3b-a1e9-52a9559200e3 33 fields · synced May 29, 2026