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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 K042972
Device Name XP TECHNOLOGY ULTRASONIC SCALER
Applicant
American Eagle Instruments, Inc.
6575 Butler Creek Rd.
Missoula,  MT  59808
Applicant Contact TOM THOMPSON
Correspondent
American Eagle Instruments, Inc.
6575 Butler Creek Rd.
Missoula,  MT  59808
Correspondent Contact TOM THOMPSON
Regulation Number872.4850
Classification Product Code
ELC  
Date Received10/28/2004
Decision Date 03/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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