Identity
- Trade Name
- Transluma ISO#120 Drill 2eaPkg FDA UDI
- Generic Name
- Pin/post dental drill bit FDA UDI
- Model / Reference
- X-81623P FDA UDI
Identifiers
- Catalog Number
- X-81623P FDA UDI
- Primary DI / UDI-DI
- D757X81623P1 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Pin/post dental drill bit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Transluma ISO#120 Drill 2eaPkg by Bisco Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Bisco Inc.
Sources (1)
- FDA UDI e95d1eb9-0f26-4bef-909f-12837fdc8d6a 36 fields · synced May 29, 2026