Heraeus Kulzer, LLC.

How does FDA spell Heraeus Kulzer, LLC.?

FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Heraeus Kulzer, LLC. file in?

60 product codes, ranked by how much they file in each.

Showing the 25 they file in most, of 60.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Heraeus Kulzer, LLC. had a recall?

openFDA lists 6 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

• Z-1651-2014Class IITerminatedLBH23 April 2014

  The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering.

• Z-1133-2014Class IITerminatedKZP10 February 2014

  As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C

• Z-0624-05TerminatedELW1 November 2003

  Packaging defects could result in improper mixing ratios and unusable impressions.

• Z-0625-05TerminatedELW1 November 2003

  Packaging defects could result in improper mixing ratios and unusable impressions.

• Z-0626-05TerminatedELW1 November 2003

  Packaging defects could result in improper mixing ratios and unusable impressions.

Showing the 5 most recently initiated of 6.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Heraeus Kulzer, LLC. cleared recently?

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z