510(k) K101029 ยท ELM Denture, Plastic, Teeth
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
| Applicant | Huge Dental Material Co., Ltd., Dover DE, US |
| Decision | Substantially Equivalent, Aug 16, 2010 |
| Received | Apr 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101029
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.