510(k) K123278 ยท KLE Agent, Tooth Bonding, Resin
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
| Applicant | Heraeus Kulzer, LLC, South Bend IN, US |
| Decision | Substantially Equivalent, Dec 7, 2012 |
| Received | Oct 22, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123278
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.