Company ยท US
Kerr Corp
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2026. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (1 in 12 months)
64recalls (0 in 12 months)
59recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 52 |
| KLE | Agent, Tooth Bonding, Resin | 14 |
| ELW | Material, Impression | 9 |
| EMA | Cement, Dental | 8 |
| EBZ | Activator, Ultraviolet, For Polymerization | 6 |
| MVL | Cord, Retraction | 5 |
| KIF | Resin, Root Canal Filling | 2 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | 2 |
| EBA | Light, Surgical Headlight | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EJJ | Alloy, Amalgam | 1 |
| FSP | Loupe, Diagnostic/Surgical | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 |
| NTK | Light Transmission Caries Detector | 1 |
| NYL | Handpiece, Air-Powered, Root Canal Irrigation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 2026 | K252890 | ZenSeal Pro Kerr Corporation | KIF |
| Jan 12, 2023 | K222830 | Rainbow 360 Kerr Corporation | KLE |
| Aug 31, 2022 | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow Kerr Corporation | EBF |
| Oct 11, 2019 | K191548 | Nexus Universal Self-Cure Kerr Corporation | EMA |
| Nov 7, 2018 | K182162 | OptiBond eXTRa Universal Kerr Corporation | KLE |
| Aug 8, 2017 | K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials Kerr Corporation | MVL |
| Jul 18, 2017 | K163064 | Demi Ultra Kerr Corporation | EBZ |
| Feb 3, 2017 | K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord Kerr Corporation | MVL |
| Jan 13, 2017 | K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord Kerr Corporation | MVL |
| Dec 21, 2016 | K162436 | EndoVac Pure Kerr Corporation | NYL |
| Nov 7, 2016 | K162257 | P1145 Dental Restorative Kerr Corporation | EBF |
| Jun 30, 2016 | K160441 | Identic and KromaFaze Alginate Dental Impression Materials Kerr Corporation | ELW |
| Mar 20, 2013 | K123468 | DEMI ULTRA Kerr Corporation | EBZ |
| Feb 19, 2013 | K123595 | NEXUS RMGI Kerr Corporation | EMA |
| Jun 14, 2011 | K110747 | TEMPFLEX Kerr Corporation | EBG |
| Apr 8, 2011 | K110092 | TAKE 1 ADVANCED RIGID TRAY Kerr Corporation | ELW |
| Jan 28, 2011 | K102621 | SOLSTICE Kerr Corporation | EBZ |
| Jan 20, 2011 | K103351 | DMC COMPOSITE 2 Kerr Corporation | EBF |
| Oct 26, 2010 | K101756 | TSC Kerr Corporation | MVL |
| Oct 16, 2010 | K102163 | REALSEAL XT SEALER Kerr Corporation | KIF |
| Oct 7, 2010 | K102133 | GIRAFFE2 Kerr Corporation | MVL |
| Jul 30, 2010 | K101423 | OPTIBOND XTR Kerr Corporation | KLE |
| Apr 30, 2010 | K100347 | OPTIBOND SE Kerr Corporation | KLE |
| Mar 19, 2010 | K100083 | ESTHETICA Kerr Corporation | EBF |
| Jan 28, 2010 | K092176 | TAKE 1 ADVANCED RIGID TRAY Kerr Corporation | ELW |
| Jan 27, 2010 | K093484 | PREMISE FLOWABLE MODIFIED Kerr Corporation | EBF |
| Oct 7, 2009 | K091613 | TAKE 1 Kerr Corp. | ELW |
| May 21, 2009 | K091023 | METAMORPHOSIS Kerr Corporation | EBF |
| Apr 3, 2009 | K090292 | PREMISE MODIFIED Kerr Corp. | EBF |
| Aug 12, 2008 | K081695 | DMC COMPOSITE Kerr Corp. | EBF |
| Jan 29, 2008 | K073209 | MAXCEM 2 Kerr Corporation | MZW |
| Dec 4, 2007 | K072622 | STANDOUT 2 Kerr Corp. | ELW |
| Sep 10, 2007 | K071429 | TI2200 TRANSILLUMINATION CABLE Kerr Corporation | NTK |
| Jul 26, 2007 | K071251 | DEMI Kerr Corporation | EBZ |
| Oct 19, 2006 | K062519 | NEXUS 3 Kerr Corporation | EMA |
| Apr 28, 2006 | K060472 | PREMISE FLOWABLE Kerr Corporation | EBF |
| Nov 10, 2004 | K042888 | DEMETRON IDS CURING LIGHT Kerr Corp. | EBZ |
| Jul 3, 2003 | K031484 | STAND OUT Kerr Corp. | ELW |
| Feb 4, 2002 | K014179 | DEMETRON LC Kerr Corp. | EBZ |
| Apr 23, 2001 | K010994 | TAKE ONE BITE MODIFIED Kerr Corp. | ELW |
| Aug 10, 2000 | K001655 | PERMLASTIC 2 Kerr Corp. | ELW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2014 | Kerr Corporation 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. Terminated |
EJJ | K951663 |
| Nov 21, 2012 | Kerr Corporation 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 Loup Terminated |
FSP | None listed |
| Nov 20, 2012 | Kerr Corporation 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 Terminated |
LYC | None listed |
| Nov 20, 2012 | Kerr Corporation 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 7700100 Terminated |
EBA | None listed |
| Nov 8, 2012 | Kerr Corporation The brand name of the device is AlgiNot, a dental impression material.
Product Part Numbers
AlgiNot Intra Kit 34683
AlgiNot Volume Refill Terminated |
ELW | K050604 |
| Mar 14, 2012 | Kerr Corporation 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. Terminated |
EMA | None listed |
| Mar 2, 2012 | Kerr Corporation Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding
agent.
Item # Item Description
N01I Bond-1 Prim/Adhesive Kit
N01IAA Bond-1 Terminated |
KLE | K973388 |
| Feb 28, 2012 | Kerr Corporation Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC.
Product Usage:
The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental r Terminated |
EBF | K072545 |
| Feb 24, 2012 | Kerr Corporation 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. Terminated |
EMA | K060698 |
| Jan 27, 2012 | Kerr Corporation 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 Terminated |
MZW | K073209 |
| Jan 11, 2012 | Kerr Corporation Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 o Terminated |
EMA | None listed |
| Oct 23, 2009 | Kerr Corp 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 restor Terminated |
EMA | K982590 |
| Nov 25, 2008 | Kerr Corp PREMISE KIT, PART NO. 33882, UNIDOSE PREMISE MINI KIT, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32668, 10 PACK UNIDOSE PREMISE A2 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32665, 10 PACK UNIDOSE PREMISE D4, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32659, 10 PACK UNIDOSE PREMISE C1, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental composite Terminated |
EBF | K060472 |
Newest 50 of 64.