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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K881253
Device Name ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW
Applicant
Dentalez Group
1818 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact DONALD I GONSER
Correspondent
Dentalez Group
1818 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact DONALD I GONSER
Regulation Number872.4850
Classification Product Code
ELC  
Date Received03/23/1988
Decision Date 04/21/1988
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
Recalls CDRH Recalls
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