K192682 is an FDA 510(k) clearance for the Orthocem, Ortho Bite. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by Dentscare Ltda (Joinville, BR). The FDA issued a Cleared decision on August 14, 2020, 323 days after receiving the submission on September 26, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K192682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2019 |
| Decision Date | August 14, 2020 |
| Days to Decision | 323 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DYH - Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3750 |