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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name agent, tooth bonding, resin
510(k) Number K972101
Device Name SOLITAIRE
Applicant
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND,  IN  46614 -2517
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND,  IN  46614 -2517
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/04/1997
Decision Date 09/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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