APEX 90


Device Classification Name

alloy, gold-based noble metal

510(k) Number K030206
Device Name APEX 90
Original Applicant
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
1733 canton ln.
marietta, 
GA 
30062

Original Contact ronald d arkin
Regulation Number 872.3060
Classification Product Code
EJT  
Date Received 01/21/2003
Decision Date 01/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No