PROVISA CEM


Device Classification Name

zinc oxide eugenol

510(k) Number K073539
Device Name PROVISA CEM
Applicant
CAVEX HOLLAND B.V.
po box 852
haarlem (holland), 

NL

2003 rw

Applicant Contact richard woortman
Correspondent
CAVEX HOLLAND B.V.
po box 852
haarlem (holland), 

NL

2003 rw

Correspodent Contact richard woortman
Regulation Number 872.3275
Classification Product Code
EMB  
Date Received 12/17/2007
Decision Date 01/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No