Jeneric/Pentron, Inc.
United StatesFDA applicant, unverified
- Devices
- 78
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Jeneric/Pentron, Inc. makes
Jeneric/Pentron, Inc. manufactures dental restorative and prosthetic materials, including crown and bridge composite systems, dual-cure activators, dental glazes and sealants, casting alloys, core posts, and light-curing units. Specific products include the Conquest C&B VLC Glaze/Sealant, Bond-It Dual Cure Activator, Jewel Cast III, Nugold 2%, Avante Curelight, Gold Core Post Solder, Build-It FR, and Procom.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Jeneric/Pentron, Inc. is based in the United States.
Catalogue
Search and filter all 78 devicesShowing 1-50 of 78
FDA recalls
FDA recall records list 1 recall initiated by Jeneric/Pentron, Inc., initiated on 2009-10-22. By recorded status: 1 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 22 Oct 2009 Z-0482-2010 Unclassified (pre-2012) Terminated Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.
Frequently asked questions
How many devices does Jeneric/Pentron, Inc. have in the registry?
The registry currently lists 78 devices for Jeneric/Pentron, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jeneric/Pentron, Inc.'s devices?
Among its 50 most recently registered devices, Jeneric/Pentron, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Jeneric/Pentron, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Jeneric/Pentron, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Jeneric/Pentron, Inc.?
FDA recall records list 1 recall initiated by Jeneric/Pentron, Inc., the most recent initiated on 22 Oct 2009. 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 Jeneric/Pentron, Inc. in the registry?
The most recently registered devices listed for Jeneric/Pentron, Inc. include KB58-KF, PROP. CONQUEST C&B VLC GLAZE/SEALANT, CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST and OROSPHERE HCDP.