510(k) K060646 ยท EBZ Activator, Ultraviolet, For Polymerization
BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855
| Applicant | Monitex Industrial Co., Ltd., Hsin-Chu City, TW |
| Decision | Substantially Equivalent, Apr 21, 2006 |
| Received | Mar 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060646
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2018 | Handpiece Headquarters Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Sc Open, Classified |
EBZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.