510(k) K991808 ยท KLE Agent, Tooth Bonding, Resin
OPTIBOND SOLO PLUS 2
| Applicant | Sybron Dental Specialties, Inc., Orange CA, US |
| Decision | Substantially Equivalent, Jul 9, 1999 |
| Received | May 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2006 | Kerr Corp OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966 Terminated |
KLE | None listed |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Optibond Solo Plus, Part Number 31513, Lot Numbers 427936, 428569, & 428290 Terminated |
KLE | None listed |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106 Terminated |
KLE | None listed |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Optibond Solo Plus Dual Cure Kit, Part Number 31736, Lot Number 427793 Terminated |
KLE | None listed |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Nexus 2 Kit, Part Number 31954, Lot Number 428572 Terminated |
KLE | None listed |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Nexus 2 Starter Kit, Part Number 31955, Lot Numbers 428570 & 429640 Terminated |
KLE | None listed |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Premise Master Syringe Kit, Part Number 32611, Lot Numbers 428730 Terminated |
KLE | None listed |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Premise Master Unidose Kit, Part Number 32612, Lot Numbers 428576 Terminated |
KLE | None listed |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Premise Starter Unidose Kit, Part Number 32684, Lot Numbers 427915 Terminated |
KLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.