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KERR CORPORATION

Last updated September 17, 2026

What KERR CORPORATION makes

The company produces dental restorative materials, including light-cured and conventional composite resin fillings, preformed root canal posts, and dentine bonding agents. It also manufactures silicone impression materials for dental molds, porcelain/ceramic restoration kits, and single-use rotary/reciprocating endodontic files. Additional products include sterilization packaging and dispensing tools for dental applications.

These devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U), and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Kerr Corporation manufacture?

Kerr Corporation specializes in dental devices, primarily producing restorative materials like light-cured and conventional composite resin fillings (e.g., Herculite XRV, Flow-It ALC). It also manufactures preformed root canal posts (e.g., Point 4), dentine bonding agents (e.g., Take 1 Advanced), silicone dental impression materials, porcelain/ceramic restoration kits, and single-use rotary/reciprocating endodontic files (e.g., FibreKleer 4x). Additional products include sterilization packaging and dental dispensing tools, all designed for dental procedures.

Where is Kerr Corporation based, and how does that affect its devices?

Kerr Corporation is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device standards. The U.S. regulatory framework applies to classifications like Class I (low-risk devices), Class II (moderate-risk devices requiring special controls), and Unclassified (U) devices, depending on the specific product.

Which regulatory registries list Kerr Corporation’s devices?

Kerr Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling tracking, transparency, and compliance verification. This registry is essential for healthcare providers, regulators, and supply chain partners to identify and validate the devices in use.

How are Kerr Corporation’s devices classified under FDA regulations?

Kerr Corporation’s devices fall into different FDA classifications based on risk and intended use. Light-cured composites and bonding agents, for example, are often classified as Class II due to their moderate risk and need for performance standards. Single-use items like rotary files or sterilization packaging may qualify as Class I (lower risk) or Unclassified (U) if they don’t fit standard Class I/II criteria. Classification determines regulatory requirements, such as pre-market submissions or post-market surveillance.

What kinds of dental materials does Kerr Corporation focus on, and why are these important?

Kerr Corporation focuses on dental restorative and impression materials, including composite resins (for fillings), silicone impression materials (for molds), and porcelain/ceramic kits (for durable restorations). These materials are critical in dental procedures because they restore function and aesthetics, seal teeth to prevent decay, and create accurate molds for crowns or bridges. The company’s products are designed to meet clinical needs while adhering to regulatory standards for safety and efficacy.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 1889 W Mission Blvd, Pomona, CA, 91766
Website: kavokerrgroup.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +18005377123
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3012477813
DUNS Number: 847905890

Catalogue (1488)

Page 27 of 30

Device	Model / Reference	Registries	Class	Status
SonicFill	34921	FDA UDI	Class II	Active
Flex Tab	004-007	FDA UDI	Class I	Active
Point 4	29907	FDA UDI	Class II	Active
Herculite XRV	29844	FDA UDI	Class II	Active
Flow-It ALC	N11XB	FDA UDI	Class II	Active
Kolor + Plus	23396	FDA UDI	Class II	Active
Ultrasonic Tips	973-0055	FDA UDI	Class II	Active
Premise	32661	FDA UDI	Class II	Active
Premise Indirect	33798	FDA UDI	Class II	Active
Impression Tray	Q17D	FDA UDI	Class I	Active
Point 4	29882	FDA UDI	Class II	Active
Revolution Formula 2	34981	FDA UDI	Class II	Active
Contour	29973	FDA UDI	Class II	Active
XRay Thyroid Protector	31455DX	FDA UDI	Class I	Active
Bond-1	N01IAC	FDA UDI	Class II	Active
ZenFlex	818-1201	FDA UDI	Class I	Active
Sterilization Mirrors	32202	FDA UDI	Class I	Active
Breeze	N97F	FDA UDI	Class II	Active
Premise	32612	FDA UDI	Class II	Active
Mojo	N06C	FDA UDI	Class II	Active
Maxcem Elite	34417	FDA UDI	Class II	Active
Extrude	28416	EUDAMEDFDA UDI	Class II	Active
Harmonize	36425	FDA UDI	Class II	Active
ZenFlex	818-1303	FDA UDI	Class I	Active
Extrude	28415	EUDAMEDFDA UDI	Class II	Active
PeelVue+	31611	FDA UDI	Class II	Active
Flow-It ALC	N11VV	FDA UDI	Class II	Active
SonicFill 2	36053	FDA UDI	Class II	Active
Extruder	28747	FDA UDI	Class I	Active
Revolution Formula 2	34969	FDA UDI	Class II	Active
Nx3	33656	FDA UDI	Class II	Active
Touch 'n Heat	973-0212	FDA UDI	Class II	Active
Expasyl	34621	FDA UDI	U	Active
Nx3	33649	FDA UDI	Class II	Active
TempSpan	N69AE	FDA UDI	Class II	Active
Build-It FR	N32FSA	FDA UDI	Class II	Active
Flow-It ALC	N11VL	FDA UDI	Class II	Active
FibreKor	N18AF	FDA UDI	Class I	Active
Sterilization Mirrors	32207	FDA UDI	Class I	Active
Revolution Formula 2	29502	FDA UDI	Class II	Active
FibreKor	N18AE	FDA UDI	Class I	Active
Light Guide	20941	FDA UDI	Class II	Active
Harmonize	36443	FDA UDI	Class II	Active
Build-It FR	N32AE	FDA UDI	Class II	Active
Flow-It ALC	N11VP	FDA UDI	Class II	Active
Artiste	N36BG	FDA UDI	Class II	Active
Nx3	33659	FDA UDI	Class II	Active
SonicFill	35073-A1	FDA UDI	Class II	Active
Vertise Flow	34249	FDA UDI	Class II	Active
Revolution Formula 2	34971	FDA UDI	Class II	Active

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FDA Recalls (64)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Kerr Corporation has initiated 64 recall records between March 3, 2006, and May 29, 2014, all of which are recorded as terminated. The recalls involve dental and medical devices, with reasons including permanent marking issues (e.g., laser loupes), material defects (e.g., resin separation, stiffening, or improper curing), mis-packaging/mis-labeling (e.g., adhesive products reversed), performance inconsistencies (e.g., bonding failure, flowability issues), and component malfunctions (e.g., polymerized catalyst, incorrect electronics in headlights). Some recalls cite deviations from specified behavior, such as faster-than-expected setting times or altered handling properties.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 29, 2014	Z-1788-2014	—	terminated	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.
Oct 25, 2012	Z-0401-2013	—	terminated	The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
Apr 10, 2012	Z-0414-2013	—	terminated	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.
Feb 21, 2012	Z-0268-2013	—	terminated	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.
Nov 17, 2011	Z-0402-2013	—	terminated	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.
Mar 3, 2011	Z-1205-2012	—	terminated	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.
Mar 3, 2011	Z-0455-2012	—	terminated	The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.
Feb 3, 2011	Z-0915-2012	—	terminated	The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds.
Dec 2, 2010	Z-1100-2012	—	terminated	The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength.
Aug 19, 2010	Z-1115-2012	—	terminated	A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected.
May 27, 2010	Z-1142-2012	—	terminated	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.
Sep 9, 2009	Z-0074-2010	—	terminated	The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
Sep 5, 2008	Z-0241-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0255-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0270-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0251-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0244-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0230-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0267-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0240-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0235-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0259-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0258-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0254-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0252-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0232-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0243-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0269-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0260-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0268-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0264-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0250-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0239-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0234-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0242-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0247-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0257-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0231-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0238-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0249-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0233-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0261-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0256-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0237-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0246-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0265-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0236-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0245-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0253-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0248-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0229-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0266-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0262-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Sep 5, 2008	Z-0263-2009	—	terminated	Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Aug 29, 2006	Z-1521-06	—	terminated	Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.
Aug 14, 2006	Z-1524-06	—	terminated	Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)
Mar 3, 2006	Z-0689-06	—	terminated	The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
Mar 3, 2006	Z-0693-06	—	terminated	The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
Mar 3, 2006	Z-0691-06	—	terminated	The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
Mar 3, 2006	Z-0690-06	—	terminated	The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
Mar 3, 2006	Z-0686-06	—	terminated	The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
Mar 3, 2006	Z-0692-06	—	terminated	The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
Mar 3, 2006	Z-0688-06	—	terminated	The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
Mar 3, 2006	Z-0687-06	—	terminated	The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.