510(k) K973388 ยท KLE Agent, Tooth Bonding, Resin
DENTIN CONDITIONING AND ADHESIVE (BOND 1)
| Applicant | Jeneric/Pentron, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Sep 12, 1997 |
| Received | Sep 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973388
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2012 | Kerr Corporation Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding
agent.
Item # Item Description
N01I Bond-1 Prim/Adhesive Kit
N01IAA Bond-1 Terminated |
KLE | None listed |
| Mar 16, 2010 | Sybron Dental Specialties Bond-1 Primer/Adhesive.
The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bondi Terminated |
KLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.