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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K853091
Device Name CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE
Applicant
Psp Dental Co., Ltd.
3-5 Dylan Rd.
Belvedere, Kent,  GB DA17 5QS
Correspondent
Psp Dental Co., Ltd.
3-5 Dylan Rd.
Belvedere, Kent,  GB DA17 5QS
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/23/1985
Decision Date 01/21/1986
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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