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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
Model 317001
Device Name TIGRAN PERIBRUSH
Applicant
TIGRAN TECHNOLOGIES AB
medeon science park
malmo, 
Contact ulf lundgren
Regulation Number872.4840
Classification Product Code
ELB  
Date Received04/12/2012
Decision Date 09/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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