Astra Tech, Inc.
United StatesFDA applicant, unverified
- Devices
- 38
What Astra Tech, Inc. makes
Astra Tech, Inc. manufactures dental implant systems, including zirconia abutments and crown abutments for brands like Dentsply Ankylos and Nobel Replace, as well as ceramic abutments for dental implants. Their portfolio also includes single-use urinary catheters, such as the LoFric Primo and LoFric Hydro-Kit II, with modifications to existing designs. The company produces dental implant fixtures under the Astra Tech Implant Dental System, including micromacro fixtures.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. Astra Tech, Inc. is based in the United States.
Catalogue
Search and filter all 38 devicesFrequently asked questions
How many devices does Astra Tech, Inc. have in the registry?
The registry currently lists 38 devices for Astra Tech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Astra Tech, Inc.'s devices?
Among its 38 most recently registered devices, Astra Tech, Inc. has devices listed in FDA 510(k) (38 devices).
What risk classes do Astra Tech, Inc.'s devices fall under?
Among its 38 most recently registered devices, the classes recorded for Astra Tech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Astra Tech, Inc. in the registry?
The most recently registered devices listed for Astra Tech, Inc. include ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA, ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL, OSSEOSPEED TM PROFILE SYSTEM and MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER.