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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K923384
Device Name ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED
Applicant
L.C. Dental
1819 So. May St.
Unit 2f
Chicago,  IL  60608
Applicant Contact ROBERT W BAUER
Correspondent
L.C. Dental
1819 So. May St.
Unit 2f
Chicago,  IL  60608
Correspondent Contact ROBERT W BAUER
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received05/28/1992
Decision Date 01/11/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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