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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K991577
Device Name NIC TONE ACRYLIC RESINS
Applicant
Manufacturera Dental Continental
30001 Golden Hartern #334
Haguna Nyvel,  CA  92677
Applicant Contact GARY MOCNIK
Correspondent
Manufacturera Dental Continental
30001 Golden Hartern #334
Haguna Nyvel,  CA  92677
Correspondent Contact GARY MOCNIK
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
EBG   OCL  
Date Received05/06/1999
Decision Date 09/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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