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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dental Amalgam
510(k) Number K140125
Device Name NEW STETIC DENTAL AMALGAM ALLOY
Applicant
NEW STETIC
445 APOLLO BEACH BLVD
APOLLO BEACH,  FL  33572
Applicant Contact JOHN O'BRIEN
Correspondent
NEW STETIC
445 APOLLO BEACH BLVD
APOLLO BEACH,  FL  33572
Correspondent Contact JOHN O'BRIEN
Regulation Number872.3070
Classification Product Code
OIV  
Subsequent Product Codes
EJJ   ELY  
Date Received01/16/2014
Decision Date 04/29/2014
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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