K233252 is an FDA 510(k) clearance for the Straumann CARES Visual and Nova Dental CAD. This device is classified as a Dental Abutment Design Software For Dental Laboratory (Class II - Special Controls, product code PNP).
Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on December 26, 2024, 455 days after receiving the submission on September 28, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And Cam Or Create That Component At A Dental Office Or Dental Laboratory Following The Directions Of The Dental Implant System. The Abutment-to-implant Interface/connection Platform Is Not A Patient-specific Component Of The Dental Abutment..
| 510(k) Number | K233252 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | December 26, 2024 |
| Days to Decision | 455 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PNP — Dental Abutment Design Software For Dental Laboratory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And Cam Or Create That Component At A Dental Office Or Dental Laboratory Following The Directions Of The Dental Implant System. The Abutment-to-implant Interface/connection Platform Is Not A Patient-specific Component Of The Dental Abutment. |