Medical Device Manufacturer · US , Port Ludlow , WA

Opti-Max - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1995

Recent clearances: OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Opti-Max Dental ✕

6 devices

1-6 of 6

Cleared Nov 13, 1997

OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25...

Cleared May 24, 1996

OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL...

Cleared May 06, 1996

OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH...

Cleared Sep 21, 1995

OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE...

Cleared Sep 18, 1995

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM...

Cleared Mar 13, 1995

OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL