Kerr Corporation
Kerr Corporation holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2026, with 5 FDA device recalls on record.
Top product codes for Kerr Corporation
FDA recalls by Kerr Corporation
- Z-1788-2014 — 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.
- Z-0401-2013 — 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.
- Z-0414-2013 — 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.
- Z-0268-2013 — 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.
- Z-0402-2013 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Kerr Corporation
- K252890 — ZenSeal Pro
- K222830 — Rainbow 360
- K221255 — SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
- K191548 — Nexus Universal Self-Cure
- K182162 — OptiBond eXTRa Universal
- K162948 — Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
- K163064 — Demi Ultra
- K162536 — GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
- K162164 — GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
- K162436 — EndoVac Pure
- K162257 — P1145 Dental Restorative
- K160441 — Identic and KromaFaze Alginate Dental Impression Materials
- K123468 — DEMI ULTRA
- K123595 — NEXUS RMGI
- K110747 — TEMPFLEX
- K110092 — TAKE 1 ADVANCED RIGID TRAY
- K102621 — SOLSTICE
- K103351 — DMC COMPOSITE 2
- K101756 — TSC
- K102163 — REALSEAL XT SEALER
- K102133 — GIRAFFE2
- K101423 — OPTIBOND XTR
- K100347 — OPTIBOND SE
- K100083 — ESTHETICA
- K092176 — TAKE 1 ADVANCED RIGID TRAY
- K093484 — PREMISE FLOWABLE MODIFIED
- K091023 — METAMORPHOSIS
- K073209 — MAXCEM 2
- K071429 — TI2200 TRANSILLUMINATION CABLE
- K071251 — DEMI
- K062519 — NEXUS 3
- K060472 — PREMISE FLOWABLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.