Identity
- Trade Name
- MINIM FDA UDI
- Generic Name
- Dental restoration retention pin FDA UDI
- Device Name
- REGULAR Bending Tool FDA UDI
- Model / Reference
- B61R FDA UDI
- Description
- REGULAR Bending Tool FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661B61R0 FDA UDI
- FDA Product Code
- EBL FDA UDI
- GMDN Term
- Dental restoration retention pin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Dental restoration retention pin
Minim by Coltene/Whaledent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental restoration retention pin.
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Ena Post — MICERIUM SPA · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class II
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI 28a6e763-9aee-49de-9e09-dda255708457 33 fields · synced Jun 9, 2026