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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K810813
Device Name DMG-POLISHABLE COMPOSITE
Applicant
Dental-Material Gesellschaft
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dental-Material Gesellschaft
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3310
Classification Product Code
EBD  
Date Received03/24/1981
Decision Date 04/14/1981
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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