Craft Dental Laboratory, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Craft Dental Laboratory, Inc. makes
Craft Dental Laboratory, Inc. manufactures Zonarex Final Impression Compounds, including variants designed for operatory heat applications. These products are used in dental laboratories to create precise final impressions for dental prosthetics, ensuring accurate mold replication for crowns, bridges, and other restorative work.
The company’s portfolio is classified under FDA Class II devices and is listed via the 510(k) pathway. The products are regulated under US medical device laws and are intended for commercial distribution within the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Zonarex Final Impression Compound Ref K896786
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Craft Dental Laboratory, Inc. have in the registry?
The registry currently lists 2 devices for Craft Dental Laboratory, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Craft Dental Laboratory, Inc.'s devices?
Among its 2 most recently registered devices, Craft Dental Laboratory, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Craft Dental Laboratory, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Craft Dental Laboratory, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Craft Dental Laboratory, Inc. in the registry?
The most recently registered devices listed for Craft Dental Laboratory, Inc. include ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ and ZONAREX FINAL IMPRESSION COMPOUND.