K190059 is an FDA 510(k) clearance for the CEREC Guides. 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 27, 2019, 259 days after receiving the submission on January 11, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3980.
| 510(k) Number | K190059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2019 |
| Decision Date | September 27, 2019 |
| Days to Decision | 259 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 |