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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K893794
Device Name APEXIT ROOT CANAL SEALER
Applicant
Williams Dental Co., Inc.
2948 Main St.
Buffalo,  NY  14214
Applicant Contact L SEVERANCE
Correspondent
Williams Dental Co., Inc.
2948 Main St.
Buffalo,  NY  14214
Correspondent Contact L SEVERANCE
Regulation Number872.3820
Classification Product Code
KIF  
Date Received05/22/1989
Decision Date 11/29/1989
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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