Identity
- Trade Name
- KLOCKNER FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- EC 12° CIRCULAR TITANIUM ABUTMENT FDA UDI
- Model / Reference
- 10 13 14 FDA UDI
- Description
- EC 12° CIRCULAR TITANIUM ABUTMENT FDA UDI
Identifiers
- Catalog Number
- 10 13 14 FDA UDI
- Primary DI / UDI-DI
- 08435451602442 FDA UDI
- 510(k) Number
- K080224 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure kit 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
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
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: Dental implant suprastructure kit
Klockner by Soadco, S.l. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 d7b160e3-53a6-4da5-8a61-06ab72d6087e 36 fields · synced May 31, 2026