K010132 is an FDA 510(k) clearance for the KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by SOADCO, S.L. (Escaldes-Engordany, AD). The FDA issued a Cleared decision on June 4, 2002, 504 days after receiving the submission on January 16, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K010132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2001 |
| Decision Date | June 04, 2002 |
| Days to Decision | 504 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |