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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 K243951
Device Name TEMP MASTER, PMMA-based dental resin
Applicant
Taiwan Dental Materials Co., Ltd.
11f., # 136, Sec. 3, Zhongxiao E. Rd., Da’An Dist.
Taipei,  TW 106671
Applicant Contact Pey-Fen Tang
Correspondent
Taiwan Dental Materials Co., Ltd.
11f., # 136, Sec. 3, Zhongxiao E. Rd., Da’An Dist.
Taipei,  TW 106671
Correspondent Contact Pey-Fen Tang
Regulation Number872.3770
Classification Product Code
EBG  
Date Received12/23/2024
Decision Date 02/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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