Ortek Therapeutics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Ortek Therapeutics, Inc. makes
Ortek Therapeutics, Inc. manufactures electrical impedance-based dental caries detectors, including handheld devices designed to identify tooth decay by measuring resistance in dental tissue. The PROCLUDE and PROCLUDE-SENSITIVE models are intended for use in clinical settings to assess caries risk and monitor treatment progress.
The company’s devices are classified as Class I and Class II under FDA regulations, with some models authorised via the 510(k) pathway and others listed under the FDA’s Unique Device Identifier (UDI) system. These products are intended for use in the United States.
Catalogue
- Registry: GUDID
Proclude Ref K002989
Regimes: 510(k) Registry: 510(k)Proclude-Sensitive Ref K003482
Regimes: 510(k) Registry: 510(k)Electronic Caries Detector Ref K170822
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 849786749
Frequently asked questions
How many devices does Ortek Therapeutics, Inc. have in the registry?
The registry currently lists 4 devices for Ortek Therapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortek Therapeutics, Inc.'s devices?
Among its 4 most recently registered devices, Ortek Therapeutics, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ortek Therapeutics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ortek Therapeutics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortek Therapeutics, Inc. in the registry?
The most recently registered devices listed for Ortek Therapeutics, Inc. include Ortek Therapeutics, Inc. Ortek-ECD, PROCLUDE, PROCLUDE-SENSITIVE and Electronic Caries Detector.