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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, tooth shade, resin
510(k) Number K121735
Device Name FIBER DISK AND BLOCK PERMANENT, TRINIA
Applicant
BIOLOREN SRL
VIA ALESSANDRO VOLTA 59
SARONNO, VA,  IT 21047
Applicant Contact RATTI ANDREA
Correspondent
BIOLOREN SRL
VIA ALESSANDRO VOLTA 59
SARONNO, VA,  IT 21047
Correspondent Contact RATTI ANDREA
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/13/2012
Decision Date 02/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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