Heraeus Kulzer, Inc.
Country not established
- Devices
- 170
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Heraeus Kulzer, Inc. makes
Heraeus Kulzer, Inc. manufactures diagnostic reagents and analyzers for glucose monitoring, including test strips, control solutions, and blood glucose meters, as well as urinalysis negative control strips for automated systems. The company also produces dental materials like rapid-cure repair composites, bonding agents, and dental alloys, alongside specialized dental impression materials and pre-vision filling systems. Additionally, it supplies medical devices such as a glucose reagent test system and a dental stent for sinus lift procedures.
The company’s portfolio includes devices classified as Class I, Class II, and Unclassified (U) under FDA regulations, with many products cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory authorization status. The manufacturer operates from the United States.
Catalogue
Search and filter all 170 devicesShowing 1-50 of 170
FDA recalls
FDA recall records list 6 recalls initiated by Heraeus Kulzer, Inc., the earliest on 2003-11-01 and the most recent on 2014-04-23. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 23 Apr 2014 Z-1651-2014 Class II Terminated 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.
Full distribution text
- 10 Feb 2014 Z-1133-2014 Class II Terminated 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
Full distribution text
- 23 Apr 2014 Z-1651-2014 Class II Terminated 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.
2003
- 1 Nov 2003 Z-0624-05 Unclassified (pre-2012) Terminated Packaging defects could result in improper mixing ratios and unusable impressions.
- 1 Nov 2003 Z-0625-05 Unclassified (pre-2012) Terminated Packaging defects could result in improper mixing ratios and unusable impressions.
- 1 Nov 2003 Z-0626-05 Unclassified (pre-2012) Terminated Packaging defects could result in improper mixing ratios and unusable impressions.
- 1 Nov 2003 Z-0627-05 Unclassified (pre-2012) Terminated Packaging defects could result in improper mixing ratios and unusable impressions.
Frequently asked questions
How many devices does Heraeus Kulzer, Inc. have in the registry?
The registry currently lists 170 devices for Heraeus Kulzer, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heraeus Kulzer, Inc.'s devices?
Among its 50 most recently registered devices, Heraeus Kulzer, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Heraeus Kulzer, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Heraeus Kulzer, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Heraeus Kulzer, Inc.?
FDA recall records list 6 recalls initiated by Heraeus Kulzer, Inc., the most recent initiated on 2014-04-23. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Heraeus Kulzer, Inc. in the registry?
The most recently registered devices listed for Heraeus Kulzer, Inc. include CLINISTAT GLUCOSE REAGENT TEST, HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM, AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM and NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS).