K012882 is an FDA 510(k) clearance for the BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060. This device is classified as a Resin, Denture, Relining, Repairing, Rebasing (Class II - Special Controls, product code EBI).
Submitted by Thermoelastic Technologies, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on November 14, 2001, 78 days after receiving the submission on August 28, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3760.
| 510(k) Number | K012882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2001 |
| Decision Date | November 14, 2001 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBI — Resin, Denture, Relining, Repairing, Rebasing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3760 |