K191590 is an FDA 510(k) clearance for the AA temp temporary restoration 3D printing photoreactive resin. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Enlighten Materials Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on May 5, 2020, 326 days after receiving the submission on June 14, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K191590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2019 |
| Decision Date | May 05, 2020 |
| Days to Decision | 326 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG - Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |