Klockner Kit Externa
Klockner Kit Externa is a Class II device made by Soadco, S.L., cleared under FDA 510(k) K173642 on 2 Oct 2018 and listed in FDA GUDID since 14 Feb 2025 (UDI-DI 08435451617804), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08435451617804 | Date14 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173642 | Date2 Oct 2018 | StatusActive |
Official records
- AccessGUDID record 08435451617804
- FDA 510(k) database K173642
Across registries
- FDA 510(k) K173642 decided 2 Oct 2018 Active
- FDA GUDID UDI-DI 08435451617804 listed 14 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K173642
- Listed FDA GUDID 08435451617804
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Klockner
- Generic name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable
- Model / Ref / Catalog
- KIT EXTERNA
- Primary DI / UDI-DI
- 08435451617804
- 510(k) Number
- FDA product code
- KCT
- GMDN term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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