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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 K981990
Device Name MRS-400, MAXI 400, MRSL-400, MAXI 400L
Applicant
D.B.I. America Corp.
8194 Woodland Center Blvd.
Tampa,  FL  33614
Applicant Contact UBIRACI R FERNANDES
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/08/1998
Decision Date 06/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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