ClearanceBrief
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

CodeDeviceRecords
EBFMaterial, Tooth Shade, Resin6
EMACement, Dental3
MEDSterilant, Medical Devices1
MZWDental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 25, 2020Kerr/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
EMAK001899
K191548
Jul 5, 2019Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Terminated
MEDK931052
Sep 19, 2013Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Terminated
EBFK001899
Apr 10, 2013Kerr/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
MZWK073209
Jan 11, 2012Kerr/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
EMAK000173
Nov 14, 2011Kerr/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
EMAK060698
Nov 3, 2011Kerr/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
EBFK874189
Nov 3, 2011Kerr/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
EBFK874189
Nov 3, 2011Kerr/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
EBFK874189
Nov 3, 2011Kerr/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
EBFK874189
Nov 3, 2011Kerr/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
EBFK874189
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