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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K885115
Device Name IMD 7GX
Applicant
Medical Dental Technology Co.
4532 Telephone Rd., Suite 101
Ventura,  CA  93003
Applicant Contact JOHN S PAENG
Correspondent
Medical Dental Technology Co.
4532 Telephone Rd., Suite 101
Ventura,  CA  93003
Correspondent Contact JOHN S PAENG
Regulation Number872.4200
Classification Product Code
EFB  
Date Received12/12/1988
Decision Date 06/23/1989
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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