Heraeus Kulzer, Inc., Dental Products Division
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Heraeus Kulzer, Inc., Dental Products Division makes
Heraeus Kulzer, Inc., Dental Products Division makes dental impression materials, specifically the Flexitime Bite product, which is used for capturing occlusal relationships in dental procedures.
The Flexitime Bite device is classified as a Class II medical device and is listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Flexitime Bite Ref K082591
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Heraeus Kulzer, Inc., Dental Products Division, initiated on 2007-07-09. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 9 Jul 2007 Z-0035-2008 Unclassified (pre-2012) Terminated The material may solidify in the bottle, and thus be rendered unusable.
- 9 Jul 2007 Z-0036-2008 Unclassified (pre-2012) Terminated The material may solidify in the bottle, and thus be rendered unusable.
Frequently asked questions
How many devices does Heraeus Kulzer, Inc., Dental Products Division have in the registry?
The registry currently lists 1 device for Heraeus Kulzer, Inc., Dental Products Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heraeus Kulzer, Inc., Dental Products Division's devices?
Among its 1 most recently registered device, Heraeus Kulzer, Inc., Dental Products Division has devices listed in FDA 510(k) (1 device).
What risk classes do Heraeus Kulzer, Inc., Dental Products Division's devices fall under?
Among its 1 most recently registered device, the classes recorded for Heraeus Kulzer, Inc., Dental Products Division's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Heraeus Kulzer, Inc., Dental Products Division?
FDA recall records list 2 recalls initiated by Heraeus Kulzer, Inc., Dental Products Division, the most recent initiated on 9 Jul 2007. 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., Dental Products Division in the registry?
The most recently registered devices listed for Heraeus Kulzer, Inc., Dental Products Division include FLEXITIME BITE.