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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 K051910
Device Name MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER
Applicant
D.B.I. America Corp.
2909 Busch Lake Blvd.
Tampa,  FL  33614
Applicant Contact UBIRACI R FERNANDES
Correspondent
D.B.I. America Corp.
2909 Busch Lake Blvd.
Tampa,  FL  33614
Correspondent Contact UBIRACI R FERNANDES
Regulation Number872.4850
Classification Product Code
ELC  
Date Received07/14/2005
Decision Date 09/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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