Opti-Max
Country not established FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Opti-Max makes
Opti-Max manufactures dental implant components, including internally-hex angled crown posts (10° and 20° inclinations), externally-threaded cylindrical and coarse-threaded implants with healing screws, and externally-hexed angled crown posts (15° and 25° inclinations) for specific implant diameters. Their portfolio also covers press-fit external-hex dental implants and titanium plasma-spray coated externally-threaded implants with external hexagons.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Opti-Max Externally Threaded Cylindrical Internal Bore Dental Implant, With Healing Screw Ref K955332
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Opti-Max Press-Fit External-Hex Dental Ref K944943
Regimes: 510(k) Registry: 510(k)Opti-Max Externally Threaded External-Hex Dental Implant, Titanium Plasma-Spray Coated, With Healing Screw Ref K952634
Regimes: 510(k) Registry: 510(k)Opti-Max Body Diameter W/5mm Top W/External Hex, Externally Threaded Dental Implant Coarse Threads Ref K960022
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Optimax Tel Aviv · IL FEI 3007304332
Frequently asked questions
How many devices does Opti-Max have in the registry?
The registry currently lists 6 devices for Opti-Max. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opti-Max's devices?
Among its 6 most recently registered devices, Opti-Max has devices listed in FDA 510(k) (6 devices).
What risk classes do Opti-Max's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Opti-Max's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Opti-Max in the registry?
The most recently registered devices listed for Opti-Max include OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS, OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW, OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4 and OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL.
Which FDA establishments are linked to Opti-Max?
1 FDA establishment is linked to Opti-Max in the registry; they are listed on the company page.