K000211 is an FDA 510(k) clearance for the BUILD-IT FR. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on March 17, 2000, 53 days after receiving the submission on January 24, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K000211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2000 |
| Decision Date | March 17, 2000 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |