K203456 is an FDA 510(k) clearance for the Straumann CARES M-Series CAD/CAM System. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on June 23, 2021, 212 days after receiving the submission on November 23, 2020.
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 | K203456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2020 |
| Decision Date | June 23, 2021 |
| Days to Decision | 212 days |
| Submission Type | Special |
| 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. |