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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Diamond, Dental
510(k) Number K893844
Device Name 3D DENTAL DIAMOND ROTARY INSTRUMENTS
Applicant
Lustgarten Multi-Tech International, Inc.
1661 Worcester Rd., Suite 201
Framingham,  MA  01701
Applicant Contact STEWART LUSTGARTEN
Correspondent
Lustgarten Multi-Tech International, Inc.
1661 Worcester Rd., Suite 201
Framingham,  MA  01701
Correspondent Contact STEWART LUSTGARTEN
Regulation Number872.4535
Classification Product Code
DZP  
Date Received05/25/1989
Decision Date 08/11/1989
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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