510(k) K052106 ยท EBF Material, Tooth Shade, Resin
SIMILE FLOW
| Applicant | Pentron Clinical Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Oct 31, 2005 |
| Received | Aug 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2012 | Sybron Dental Specialties Artiste Flowable Part Number N28A, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding Terminated |
EBF | None listed |
| Feb 13, 2012 | Sybron Dental Specialties Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variet Terminated |
EBF | None listed |
| Feb 13, 2012 | Sybron Dental Specialties Flow Tec Part Number 3784-514, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding age Terminated |
EBF | None listed |
| Feb 13, 2012 | Sybron Dental Specialties Flow Tec Part Number 3786-754, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding age Terminated |
EBF | None listed |
| Feb 11, 2012 | Sybron Dental Specialties Artiste Nano-Hybrid Affected Product.
Syringe Part No. Value Pack Part. No Shade
N28A N28VA A1
N28B N28VB Terminated |
EBF | None listed |
| Feb 11, 2012 | Sybron Dental Specialties Flow Tec Nano-Hybrid Flowable Affected Product
Syringe Part No. Value Pack Part. No. Shade
BEN3784-514 BEN3786-754 A1
BEN3784-532 BEN3786-763 A2
BEN3784-541 BEN3784-738 A3
BEN3784-550 BEN3784-747 A3. Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.