Dental Concepts, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Dental Concepts, LLC makes
Dental Concepts, LLC manufactures oral health devices, including the ORAPIK Periodontal Scaler for dental cleaning procedures, as well as custom-fitted night guards and dental protectors for oral protection.
Their products are regulated under FDA Class I and Class II (U) classifications, with some devices listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Orapik Periodontal Scaler Ref K844238
Regimes: 510(k) Registry: 510(k)Doctor's Nightguard Ref K053580
Regimes: 510(k) Registry: 510(k)Dental Protector Ref K024261
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dental Concepts, LLC have in the registry?
The registry currently lists 3 devices for Dental Concepts, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dental Concepts, LLC's devices?
Among its 3 most recently registered devices, Dental Concepts, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Dental Concepts, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Dental Concepts, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dental Concepts, LLC in the registry?
The most recently registered devices listed for Dental Concepts, LLC include ORAPIK PERIODONTAL SCALER, DOCTOR'S NIGHTGUARD and DENTAL PROTECTOR.