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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations
510(k) Number K073199
Device Name 3M ESPE LAVA CHAIRSIDE ORAL SCANNER
Applicant
BRONTES TECHNOLOGIES
20310 SW 48TH ST.
SOUTHWEST RANCHES,  FL  33332
Applicant Contact JOHN GREENBAUM
Correspondent
BRONTES TECHNOLOGIES
20310 SW 48TH ST.
SOUTHWEST RANCHES,  FL  33332
Correspondent Contact JOHN GREENBAUM
Regulation Number872.3661
Classification Product Code
NOF  
Date Received11/13/2007
Decision Date 12/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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