510(k) Report

FDA applicant

Heraeus Kulzer, Inc.

South Bend, IN170 decisions1988–201344 recalls

FDA records 170 decisions for Heraeus Kulzer, Inc. (South Bend, IN) from 1988 to 2013: 170 510(k) clearances. Most are in product codes ELW (Material, Impression) and KLE (Agent, Tooth Bonding, Resin). Its devices cite 25 predicates, 16 of them its own earlier devices. 44 recalls are linked to its devices.

FDA’s records also spell it “Heraeus Kulzer, LLC”, “Heraeus Kulzer,GmbH”, “Heraeus Kulzer GmbH & Co. KG”.

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 Heraeus Kulzer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 22009: 32010: 32011: 32012: 32013: 1
2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2007: 22008: 292012: 72013: 12024: 1
2007high 29 (2008) · low 0 (2009)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • ELWMaterial, Impression21decisions
  • KLEAgent, Tooth Bonding, Resin19decisions
  • EBFMaterial, Tooth Shade, Resin18decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing13decisions
  • CGAGlucose Oxidase, Glucose10decisions
  • LODBone Cement7decisions

Also: CFR (6), LCP (4), EJT (3), ELM (3), GKZ (3), EBG (2).

Whose devices does it build on?

Its devices cite 25 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 100 times; 16 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.

  • K031673Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG · 20049cite it
  • K030902Palacos RHeraeus Kulzer GmbH & Co. KG · 20039cite it
  • K951361Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 19955cite it
  • K050085Osteopal VHeraeus Kulzer,GmbH · 20055cite it
  • K954115Artglass & KevlocHeraeus Kulzer, Inc. · 19955cite it
  • K000629FlextimeHeraeus Kulzer, Inc. · 20005cite it

What has FDA decided for it lately?

  • K130647Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50MLHeraeus Kulzer, LLC · 2013
  • K123278Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose…Heraeus Kulzer, LLC · 2012
  • K120914Flexitime Fast & Scan Light FlowHeraeus Kulzer, LLC · 2012
  • K113574Flexitime Monophase Pro ScanHeraeus Kulzer, LLC · 2012
  • K112501Venus Pearl PLT Refill A1Heraeus Kulzer, LLC · 2011
  • K111832Paladon Ultra Powder (Pink), Paladon Ultra LiquidHeraeus Kulzer, LLC · 2011
  • K110037Palaxpress Ultra Powder (Pink); Palaxpress Ultra LiquidHeraeus Kulzer, LLC · 2011
  • K102770Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium FlowHeraeus Kulzer, LLC · 2010

All 145 as Heraeus Kulzer, Inc. →All 11 as Heraeus Kulzer, LLC →All 10 as Heraeus Kulzer,GmbH →

What has been recalled?

44 recalls linked to its devices; the latest:

  • K951361DCA Systems HbA1c Reagent KitFeb 7, 2024Class II
  • K031673Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl…Nov 4, 2013Class II
  • K943780Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative Control…Nov 21, 2012Class III
  • K943780Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix…Nov 21, 2012Class III
  • K943780Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix…Nov 21, 2012Class II
  • K943780Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix Positive…Nov 21, 2012Class III

Other applicant names beginning “Heraeus”

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

Heraeus Lasersonics, Inc. 38Heraeus Medical GmbH 13Heraeus Surgical, Inc. 8Heraeus Medical Components, LLC 4Heraeus Med GmbH 3Heraeus Dental Gold Corp. 3Heraeus-Christ GmbH 2Heraeus Kulzer, LLC (Mitsui Chemicals Group) 2Heraeus Medical GmbH Technology 1Heraeus Instruments GmbH 1Heraeus, Inc. 1Heraeus Kulzer, Inc., Dental Products Division 1