510(k) K874189 ยท EBF Material, Tooth Shade, Resin
DUAL-CURE RADIOPAQUE
| Applicant | Pentron Corp., Wallingford CT, US |
| Decision | Substantially Equivalent, Feb 11, 1988 |
| Received | Oct 14, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874189
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2011 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical 37% Etching Gel-1ml syringe, part # T06
The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Terminated |
EBF | None listed |
| Nov 3, 2011 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical 37% Etching Gel-1ml syringe 20 pk, part # T06A
The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Terminated |
EBF | None listed |
| Nov 3, 2011 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical 37% Etching Gel-1ml syringe 50 pk, part # T06B
The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Terminated |
EBF | None listed |
| Nov 3, 2011 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical 37% Etching Gel-3ml syringe, part #N01H
The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Terminated |
EBF | None listed |
| Nov 3, 2011 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical 37% Etching Gel-5ml syringe, part #N01IB
The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.