510(k) K992048 ยท KLE Agent, Tooth Bonding, Resin
MODIFICATION OF PROMPT L-POP
| Applicant | Espe Dental AG, Bavaria D-82228 Seefeld, DE |
| Decision | Substantially Equivalent, Aug 16, 1999 |
| Received | Jun 17, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2025 | 3M Unitek Corporation 3M Unitek Transbond Plus Self-Etching Primer REF
712-090 (100 unit box)
712-091 (20 unit box)
Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bo Open, Classified |
KLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.