Instrumentarium Dental, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Instrumentarium Dental, Inc. makes
Instrumentarium Dental, Inc. manufactures volumetric tomography systems, which provide three-dimensional imaging for dental and maxillofacial diagnostics.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Volumetric Tomography Ref K063773
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Instrumentarium Dental, Inc., initiated on 2006-04-28. By recorded status: 1 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.
2006
- 28 Apr 2006 Z-0816-2007 Unclassified (pre-2012) Terminated There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.
Frequently asked questions
How many devices does Instrumentarium Dental, Inc. have in the registry?
The registry currently lists 1 device for Instrumentarium Dental, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Instrumentarium Dental, Inc.'s devices?
Among its 1 most recently registered device, Instrumentarium Dental, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Instrumentarium Dental, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Instrumentarium Dental, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Instrumentarium Dental, Inc.?
FDA recall records list 1 recall initiated by Instrumentarium Dental, Inc., the most recent initiated on 28 Apr 2006. 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 Instrumentarium Dental, Inc. in the registry?
The most recently registered devices listed for Instrumentarium Dental, Inc. include VOLUMETRIC TOMOGRAPHY.