Rite-Dent Manufacturing Corp.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Rite-Dent Manufacturing Corp. makes
Rite-Dent Manufacturing Corp. produces dental materials for restorative and preventive procedures, including zinc phosphate cement, polycarboxylate cement, tooth shade resin, cavity varnish, alginate impression material, enamel bonding systems, and chemical curing pit and fissure sealants.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates within the United States.
Catalogue
Zinc Phosphate Cement Ref K003427
Regimes: 510(k) Registry: 510(k)Tooth Shade Resin Material Ref K011453
Regimes: 510(k) Registry: 510(k)Cavity Varnish Ref K010255
Regimes: 510(k) Registry: 510(k)Alginate Impression Material Ref K003426
Regimes: 510(k) Registry: 510(k)Enamel Bonding System Ref K020050
Regimes: 510(k) Registry: 510(k)Pit And Fissure Chemical Curing Sealant Ref K011822
Regimes: 510(k) Registry: 510(k)Polycarboxylate (Pca) Cement Ref K010240
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Rite-Dent Manufacturing Corp., initiated on 2005-09-21. 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.
2005
- 21 Sep 2005 Z-0128-06 Unclassified (pre-2012) Terminated At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list.
Frequently asked questions
How many devices does Rite-Dent Manufacturing Corp. have in the registry?
The registry currently lists 7 devices for Rite-Dent Manufacturing Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rite-Dent Manufacturing Corp.'s devices?
Among its 7 most recently registered devices, Rite-Dent Manufacturing Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Rite-Dent Manufacturing Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Rite-Dent Manufacturing Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rite-Dent Manufacturing Corp.?
FDA recall records list 1 recall initiated by Rite-Dent Manufacturing Corp., the most recent initiated on 21 Sep 2005. 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 Rite-Dent Manufacturing Corp. in the registry?
The most recently registered devices listed for Rite-Dent Manufacturing Corp. include ZINC PHOSPHATE CEMENT, TOOTH SHADE RESIN MATERIAL, CAVITY VARNISH and ALGINATE IMPRESSION MATERIAL.