ARTEGRAL AND POLYSTAR SELECTION


Device Classification Name

denture, plastic, teeth

510(k) Number K030588
Device Name ARTEGRAL AND POLYSTAR SELECTION
Applicant
MERZ DENTAL GMBH
100 main st.
ste: 120
concord, 
MA 
01742

Applicant Contact james delaney
Correspondent
MERZ DENTAL GMBH
100 main st.
ste: 120
concord, 
MA 
01742

Correspodent Contact james delaney
Regulation Number 872.3590
Classification Product Code
ELM  
Date Received 02/25/2003
Decision Date 05/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No