Company
Kerr/pentron Dba Kerr Corporation And Pentron Clinical
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2020 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restora Terminated |
EMA | K001899 K191548 |
| Jul 5, 2019 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution Terminated |
MED | K931052 |
| Sep 19, 2013 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical NX3 Try-In Gel. The product is used as a tooth shade resin material. Terminated |
EBF | K001899 |
| Apr 10, 2013 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0.
Used for cementation of all indirect restorations. Terminated |
MZW | K073209 |
| Jan 11, 2012 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It).
The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Ce Terminated |
EMA | K000173 |
| Nov 14, 2011 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical Breeze Self-Adhesive Resin Cement, Part Number: N97A,
Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts Terminated |
EMA | K060698 |
| 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 | K874189 |
| 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 | K874189 |
| 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 | K874189 |
| 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 | K874189 |
| 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 | K874189 |