Edentec Corp.
United StatesFDA applicant, unverified
- Devices
- 18
What Edentec Corp. makes
Edentec Corp. manufactures dental and sleep diagnostic devices, including airflow systems like the EDENTRACE AIRFLOW 3171 and SLEEP LAB AIRFLOW 3170, as well as modular memory units (e.g., Model 2001 MMU) for data storage. Their portfolio also includes pulse oximeters (Model 2800/2801), apnea monitors (e.g., Model 2000W), and multi-channel recorders (e.g., EDENTRACE 670 System) for respiratory and oxygen saturation measurements. Additional products cover digital recorders (Model 3711), pressure meters (Model 2860), and specialized scanners (Model 4700) for dental or diagnostic use.
The company’s devices are classified under FDA’s Class I and Class II categories, with submissions recorded in the FDA’s 510(k) registry. These products are intended for use in dental and sleep diagnostics, adhering to U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 18 devicesFrequently asked questions
How many devices does Edentec Corp. have in the registry?
The registry currently lists 18 devices for Edentec Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edentec Corp.'s devices?
Among its 18 most recently registered devices, Edentec Corp. has devices listed in FDA 510(k) (18 devices).
What risk classes do Edentec Corp.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Edentec Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Edentec Corp. in the registry?
The most recently registered devices listed for Edentec Corp. include EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170, MODEL 2000W OPTION H CONFIGURATION, EDENTRACE MULTI-CHARTER MODEL 3700 and EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU).