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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name scaler, rotary
510(k) Number K121114
Device Name TIGRAN PERIBRUSH
Original Applicant
TIGRAN TECHNOLOGIES AB
medeon science park
malmo,  SE 205 12
Original Contact ulf lundgren
Regulation Number872.4840
Classification Product Code
ELB  
Date Received04/12/2012
Decision Date 09/17/2012
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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