Identity
- Trade Name
- ASTRA TECH Implant System® FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- Direct Abutment API™ 4.5/5.0 - Ø 5, 4 mm FDA UDI
- Model / Reference
- 24561 FDA UDI
- Description
- Direct Abutment API™ 4.5/5.0 - Ø 5, 4 mm FDA UDI
Identifiers
- Catalog Number
- 24561 FDA UDI
- Primary DI / UDI-DI
- 07392532067211 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure kit 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 567d41f6-9dc0-4f39-9642-67ae7868b0cb 37 fields · synced May 31, 2026