G & A Industries, Inc.
Country not established
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What G & A Industries, Inc. makes
G & A Industries, Inc. manufactures the XENEX DENTAL ROULETTE, a dental device designed for use in oral healthcare procedures.
The XENEX DENTAL ROULETTE is classified as a Class I medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
Xenex Dental Roulette Ref K880485
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by G & A Industries, Inc., initiated on 2015-04-06. 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.
2015
- 6 Apr 2015 Z-1537-2015 Class II Terminated GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release.
Frequently asked questions
How many devices does G & A Industries, Inc. have in the registry?
The registry currently lists 4 devices for G & A Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list G & A Industries, Inc.'s devices?
Among its 4 most recently registered devices, G & A Industries, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do G & A Industries, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for G & A Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for G & A Industries, Inc.?
FDA recall records list 1 recall initiated by G & A Industries, Inc., the most recent initiated on 2015-04-06. 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 G & A Industries, Inc. in the registry?
The most recently registered devices listed for G & A Industries, Inc. include Logicon Caries Detector 5.2, Logicon Caries Detector 4.0, Logicon Caries Detector 5.1 and XENEX DENTAL ROULETTE.