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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adhesive, bracket and tooth conditioner, resin
510(k) Number K994309
Device Name SOLO ORTHO 2
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Applicant Contact WENDY URTEL
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Correspondent Contact WENDY URTEL
Regulation Number872.3750
Classification Product Code
DYH  
Date Received12/21/1999
Decision Date 03/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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