K101029 is an FDA 510(k) clearance for the KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH. This device is classified as a Denture, Plastic, Teeth (Class II - Special Controls, product code ELM).
Submitted by Huge Dental Material Co., Ltd. (Dover, US). The FDA issued a Cleared decision on August 16, 2010, 125 days after receiving the submission on April 13, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3590.
| 510(k) Number | K101029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2010 |
| Decision Date | August 16, 2010 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELM - Denture, Plastic, Teeth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3590 |