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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K822451
Device Name AURAFILL* DENTAL RESTORATIVE BONDING AG.
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/16/1982
Decision Date 09/07/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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