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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 K081961
Device Name 3M UNITEK 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 Received07/09/2008
Decision Date 09/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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