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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bur, Dental
510(k) Number K920243
Device Name SMART BURS TOTAL CARBIDES
Applicant
Vermont Diamond Instruments
P.O. Box 147
River Rd.
Bridgewater Corners,  VT  05035
Applicant Contact LARRY CLARK
Correspondent
Vermont Diamond Instruments
P.O. Box 147
River Rd.
Bridgewater Corners,  VT  05035
Correspondent Contact LARRY CLARK
Regulation Number872.3240
Classification Product Code
EJL  
Date Received01/17/1992
Decision Date 03/25/1992
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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