Coltene, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Coltene, Inc. makes
Coltene, Inc. manufactures dental impression materials, including regular and specialized systems like the President Jet and President Jet Impression Materials System, designed for capturing precise dental molds. The company also produces endodontic materials, such as Coltosol Temporary Endodontic Filling Material, as well as dental restorative systems like the DRS Dental Restorative System and Brilliant D.I. Direct Inlay System. Additional offerings include jet-mixing devices, dental floss (Coltex/Coltoflax), temporary restorative materials (Coltene Oraloy, Coltene Rapid, Coltene Precise), and caps for dental equipment (Oraloy Magicaps).
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The products are listed in the FDA’s 510(k) registry. Coltene, Inc. is headquartered in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Coltene, Inc. have in the registry?
The registry currently lists 15 devices for Coltene, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coltene, Inc.'s devices?
Among its 15 most recently registered devices, Coltene, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Coltene, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Coltene, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Coltene, Inc. in the registry?
The most recently registered devices listed for Coltene, Inc. include COLTENE PRESSURE SPOT INDICATOR, COLTENE PRESIDENT JET REGULAR BODY, COOL TEMP NATURAL and COLTENE PRESIDENT IMPRESSION MATERIALS.