Identity
- Trade Name
- KLOCKNER FDA UDI
- Generic Name
- Intramucosal dental implant FDA UDI
- Device Name
- VEGA MV TITANIUM HEALING ABUTMENT [Ø3.2 x 5.0MM] FDA UDI
- Model / Reference
- 18 05 44 FDA UDI
- Description
- VEGA MV TITANIUM HEALING ABUTMENT [Ø3.2 x 5.0MM] FDA UDI
Identifiers
- Catalog Number
- 18 05 44 FDA UDI
- Primary DI / UDI-DI
- 08435451604996 FDA UDI
- 510(k) Number
- K153098 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Intramucosal dental implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- 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
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
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
Category: Intramucosal dental implant
Klockner by Soadco, S.l. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ASTRA TECH Implant System® EV — Dentsply Implants Manufacturing GmbH · Class II
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Cleared under the same submission
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
- Soadco, S.l.
Sources (1)
- FDA UDI 351b284b-6dfd-41df-9278-d0fd8fb3e66b 36 fields · synced May 30, 2026