Identity
- Trade Name
- BIOTANIUM FDA UDI
- Generic Name
- Dental soft-tissue coring punch, reusable FDA UDI
- Device Name
- 6.5mm Tissue Punch FDA UDI
- Model / Reference
- PI506 FDA UDI
- Description
- 6.5mm Tissue Punch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123454761 FDA UDI
- FDA Product Code
- EME FDA UDI
- GMDN Term
- Dental soft-tissue coring punch, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental soft-tissue coring punch, reusable
Biotanium by Basic Dental Implant Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental soft-tissue coring punch, reusable.
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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 |
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Manufacturer
- Manufacturer
- Basic Dental Implant Systems, Inc.
Sources (1)
- FDA UDI 69352692-ae5b-4474-9f98-ebb2a5886f93 33 fields · synced Jun 8, 2026