Hallim Dentech Co., Ltd.
Country not established
- Devices
- 1
What Hallim Dentech Co., Ltd. makes
Hallim Dentech Co., Ltd. manufactures the CHALLENGE-EVER, a dental device designed for oral health diagnostics, likely used in challenge tests for dental materials or restorative procedures.
The CHALLENGE-EVER is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Challenge-Ever Ref K102223
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hallim Dentech Co., Ltd. have in the registry?
The registry currently lists 1 device for Hallim Dentech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hallim Dentech Co., Ltd.'s devices?
Among its 1 most recently registered device, Hallim Dentech Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Hallim Dentech Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hallim Dentech Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hallim Dentech Co., Ltd. in the registry?
The most recently registered devices listed for Hallim Dentech Co., Ltd. include CHALLENGE-EVER.