CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE

Cement, Dental

PSP DENTAL CO., LTD.

The following data is part of a premarket notification filed by Psp Dental Co., Ltd. with the FDA for Cardchem Aquaset, Temp D, Templin, 2n Phosphate.

Pre-market Notification Details

Device IDK853091
510k NumberK853091
Device Name:CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE
ClassificationCement, Dental
Applicant PSP DENTAL CO., LTD. 3-5 DYLAN RD. Belvedere, Kent,  GB Da17 5qs
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-23
Decision Date1986-01-21

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