K193405 is an FDA 510(k) clearance for the Simplant Digital Guide. This device is classified as a Accessories, Implant, Dental, Endosseous (Class I - General Controls, product code NDP).
Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on September 2, 2020, 268 days after receiving the submission on December 9, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3980.
| 510(k) Number | K193405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2019 |
| Decision Date | September 02, 2020 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NDP — Accessories, Implant, Dental, Endosseous |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3980 |