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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Denture, Plastic, Teeth
510(k) Number K060720
Device Name CURATIVE DENTAL ACRYLIC TEETH
Applicant
Curative, LLC
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact JAMES R VEALE
Correspondent
Curative, LLC
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number872.3590
Classification Product Code
ELM  
Date Received03/17/2006
Decision Date 08/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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