K231803 is an FDA 510(k) clearance for the Neodent Implant System - Zirconia Implant System. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. (Curitiba, BR). The FDA issued a Cleared decision on December 13, 2023, 176 days after receiving the submission on June 20, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..
| 510(k) Number | K231803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NHA - Abutment, Implant, Dental, Endosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation. |