Hyunjae Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Hyunjae Corp. makes
Hyunjae Corp. manufactures dental impression materials, including a Nusil-based earmold impression material and general dental impression products. These materials are designed for creating accurate molds of oral structures for custom dental or hearing aid applications.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with some products listed via the 510(k) pathway. These products are registered in the U.S. and comply with applicable medical device regulations.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Hyunjae Dental Impression Materials Ref K962680
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hyunjae Corp. have in the registry?
The registry currently lists 2 devices for Hyunjae Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hyunjae Corp.'s devices?
Among its 2 most recently registered devices, Hyunjae Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hyunjae Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hyunjae Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hyunjae Corp. in the registry?
The most recently registered devices listed for Hyunjae Corp. include HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL and HYUNJAE DENTAL IMPRESSION MATERIALS.