K922251 is an FDA 510(k) clearance for the TI-CORE-NATURAL. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Essential Dental Systems, Inc. (Great Neck, US). The FDA issued a Cleared decision on January 26, 1994, 630 days after receiving the submission on May 6, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K922251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1992 |
| Decision Date | January 26, 1994 |
| Days to Decision | 630 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |