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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K953898
Device Name ACL-5500 PRECISION CURING UNIT (PCU)
Applicant
Ion Laser Technology
3828 S. Main St.
Salt Lake City,  UT  84115
Applicant Contact J. RAYMOND KEMPLE
Correspondent
Ion Laser Technology
3828 S. Main St.
Salt Lake City,  UT  84115
Correspondent Contact J. RAYMOND KEMPLE
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received08/18/1995
Decision Date 02/15/1996
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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