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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, operative dental
510(k) Number K000112
Device Name ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
Applicant
DENTSPLY INTL.
901 WEST OAKTON ST.
DES PLAINES,  IL  60018 -1884
Applicant Contact WILLIAM T COUSINS
Correspondent
DENTSPLY INTL.
901 WEST OAKTON ST.
DES PLAINES,  IL  60018 -1884
Correspondent Contact WILLIAM T COUSINS
Regulation Number872.6640
Classification Product Code
EIA  
Date Received01/14/2000
Decision Date 04/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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