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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K944981
Device Name 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
Applicant
3M Company
2111 Mcgaw Ave.
Irvine,  CA  92714
Applicant Contact AMY E FOWLER
Correspondent
3M Company
2111 Mcgaw Ave.
Irvine,  CA  92714
Correspondent Contact AMY E FOWLER
Regulation Number872.3770
Classification Product Code
EBG  
Date Received10/07/1994
Decision Date 12/02/1994
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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