Identity
- Trade Name
- ASTRA TECH Implant System® FDA UDI
- Generic Name
- Transgingival implant FDA UDI
- Device Name
- Profile BiAbutment 3.5 - Ø 4.5 mm FDA UDI
- Model / Reference
- 24080 FDA UDI
- Description
- Profile BiAbutment 3.5 - Ø 4.5 mm FDA UDI
Identifiers
- Catalog Number
- 24080 FDA UDI
- Primary DI / UDI-DI
- 07392532055034 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Transgingival implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
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
ASTRA TECH Implant System® by Dentsply Implants Manufacturing GmbH — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Dentsply Implants Manufacturing GmbH
Sources (1)
- FDA UDI 77517973-63bf-42a6-ac15-ecb83a65102f 37 fields · synced Jun 8, 2026