34 results · 22ms · Sources: EU EUDAMED, US FDA

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NX3 Try-In Gel. The product is used as a tooth shade resin material.

FDA Enforcement
Class II ·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·September 25, 2013

Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.

FDA Enforcement
Class II ·Terminated·Kerr Corporation·June 25, 2014

The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

FDA Enforcement
Class II ·Terminated·Kerr Corporation·November 14, 2012

Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.

FDA Recall
Terminated ·Sybron Dental Specialties·Product code EBF·February 23, 2009

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.

FDA Recall
Terminated ·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code MZW·February 22, 2013

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.

FDA Enforcement
Class II ·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·April 17, 2013

Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.

FDA Recall
Terminated ·Kerr Corporation·Product code EJJ·May 29, 2014

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 restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.

FDA Recall
Terminated ·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code EMA·February 25, 2020

NX3 Try-In Gel. The product is used as a tooth shade resin material.

FDA Recall
Terminated ·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code EBF·September 13, 2013

Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.

FDA Recall
Terminated ·Kerr Corp·Product code EMA·September 9, 2009

SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. Revolution is a flowable light cure hybrid resin restorative.

FDA Recall
Terminated ·Patterson Dental Supply, Inc.·Product code EBF·October 15, 2010

Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants

FDA Recall
Terminated ·Kerr Corporation·Product code MZW·February 3, 2011

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

FDA Recall
Terminated ·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code MED·July 13, 2018

The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

FDA Recall
Terminated ·Kerr Corporation·Product code ELW·February 21, 2012

Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.

FDA Enforcement
Class II ·Terminated·Kerr Corporation·November 28, 2012

The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.

FDA Enforcement
Class II ·Terminated·Kerr Corporation·November 28, 2012

BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.

FDA Enforcement
Class II ·Terminated·Kerr Corporation·November 28, 2012

BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.

FDA Recall
Terminated ·Kerr Corporation·Product code LYC·October 25, 2012

Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.

FDA Recall
Terminated ·Kerr Corporation·Product code EMA·December 2, 2010

The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.

FDA Recall
Terminated ·Kerr Corporation·Product code FSP·April 10, 2012