Kerr Corporation

Reports per year

Source: FDA adverse event reports by year received, 2006–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Cement, DentalEMA983
• Agent, Tooth Bonding, ResinKLE430
• Material, Tooth Shade, ResinEBF423
• Activator, Ultraviolet, For PolymerizationEBZ66
• Crown And Bridge, Temporary, ResinEBG18
• Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain ReliefMZW14
• Material, ImpressionELW13
• Bone Grafting Material, SyntheticLYC12
• Capsule, Dental, AmalgamDZS11
• Alloy, AmalgamEJJ7

Recent recalls

• 2019-07-05TerminatedError in labeling

  Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

  Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.

• 2014-06-13TerminatedUnknown/Undetermined by firm

  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.

  Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.

• 2013-09-19TerminatedMixed-up of materials/components

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

  Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.

• 2013-04-10TerminatedNonconforming Material/Component

  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.

  Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.

• 2012-11-21TerminatedFinished device change control

  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.

  The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device.

• 2012-11-20TerminatedLabeling design

  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.

  The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.

• 2012-11-20TerminatedLabeling mix-ups

  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.

  The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur.

• 2012-11-08TerminatedNonconforming Material/Component

  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.

  The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.

• 2012-03-14TerminatedNonconforming Material/Component

  Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.

  The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste, and it may set faster than specified.

• 2012-03-02TerminatedNonconforming Material/Component

  Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1 Prim/Adhesive Kit N01IAA Bond-1 Primer/Adhesive 4ml N01IAB Bond-1 Primer/Adhesive 6ml N04 Lute-it w/ Bond-1 kit N04B Lute-t w/Bond-1 Intro Kit N31B Bond-1 C&B Prim/Adhesive N33 Cement-it Universal C&B Resin. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

  The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable.