Pacific Union Dental, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Pacific Union Dental, Inc. makes
Pacific Union Dental, Inc. manufactures single-use dental impression trays, including disposable 3-inch check bite and plastic dent impression trays in nine styles. Their product line also includes stainless steel dental crown removers, root canal organizers, and plastic floss holders designed for clinical use.
The company’s devices are classified under FDA categories Class I and Class II, with submissions recorded in the FDA’s 510(k) registry. These products are intended for dental procedures and are listed under U.S. regulatory requirements.
Catalogue
Disposable 3IN Check Bite Impression Trays Ref K855112
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Root Canal Organizer Ref K860817
Regimes: 510(k) Registry: 510(k)Floss Holder (Plastic) Ref K855113
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pacific Union Dental, Inc. have in the registry?
The registry currently lists 5 devices for Pacific Union Dental, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pacific Union Dental, Inc.'s devices?
Among its 5 most recently registered devices, Pacific Union Dental, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Pacific Union Dental, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Pacific Union Dental, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pacific Union Dental, Inc. in the registry?
The most recently registered devices listed for Pacific Union Dental, Inc. include DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS, DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES, STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR and ROOT CANAL ORGANIZER.