510(k) Report

FDA applicant

Kerr Corporation

Orange, CA41 decisions2000–202646 recalls

FDA records 41 decisions for Kerr Corporation (Orange, CA) from 2000 to 2026: 41 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and ELW (Material, Impression). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 5 of them its own earlier devices. 46 recalls are linked to its devices.

FDA’s records also spell it “Kerr Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Kerr Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 32008: 22009: 32010: 82011: 42013: 22016: 32017: 42018: 12019: 12022: 12023: 12026 (partial year): 1
2007high 8 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2020

2008: 422011: 22013: 12020: 1
2007high 42 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Kerr Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kerr Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin9decisions
  • ELWMaterial, Impression8decisions
  • EBZActivator, Ultraviolet, For Polymerization6decisions
  • MVLCord, Retraction5decisions
  • KLEAgent, Tooth Bonding, Resin4decisions
  • EMACement, Dental3decisions

Also: KIF (2), EBG (1), NYL (1), MZW (1), NTK (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 121 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 158 days; 6 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K073209Maxcem 2Kerr Corporation · 20086cite it
  • K091023MetamorphosisKerr Corporation · 20092cite it
  • K091613TAKE 1Kerr Corp. · 20092cite it
  • K160441Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation · 20162cite it
  • K071429TI2200 Transillumination CableKerr Corporation · 20072cite it
  • K101423Optibond XTRKerr Corporation · 20102cite it

What has FDA decided for it lately?

  • K252890ZenSeal ProKerr Corporation · 2026
  • K222830Rainbow 360Kerr Corporation · 2023
  • K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation · 2022
  • K191548Nexus Universal Self-CureKerr Corporation · 20191 recall
  • K182162OptiBond eXTRa UniversalKerr Corporation · 2018
  • K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsKerr Corporation · 2017
  • K163064Demi UltraKerr Corporation · 2017
  • K162536GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate…Kerr Corporation · 2017

All 32 as Kerr Corporation →All 9 as Kerr Corp. →

What has been recalled?

46 recalls linked to its devices; the latest:

  • K191548Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref…Feb 25, 2020Class II
  • K073209Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC…Feb 22, 2013Class II
  • K073209Maxcem Elite (TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g…Nov 10, 2011
  • K073209Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use…Feb 3, 2011
  • K060472PREMISE, PART NO. 32652, 10 PACK UNIDOSE PREMISE A3, dental compositeSep 5, 2008
  • K060472PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental compositeSep 5, 2008

Other applicant names beginning “Kerr”

FDA records each applicant name separately; these may or may not be the same firm.

Kerr Corporation (Danbury) 32Kerr Dental Materials Center 17Kerr Hearing Aid Laboratory 1