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


Device Classification Name

implant, endosseous, root-form

510(k) Number K960022
Device Name OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS
Applicant
OPTI-MAX
6281 oak bay rd.
port ludlow, 
WA 
98365

Applicant Contact william f zingheim
Correspondent
OPTI-MAX
6281 oak bay rd.
port ludlow, 
WA 
98365

Correspodent Contact william f zingheim
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 01/02/1996
Decision Date 05/24/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No