FDA 510(k)

CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE

K-Number: K853091 · 1986-01-21

Decision Date1986-01-21

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE is the device name listed in this FDA 510(k) record. The listed applicant is Psp Dental Co., Ltd.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K853091. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE?

CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Psp Dental Co., Ltd.. The 510(k) number is K853091.

When did CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE receive FDA 510(k) clearance?

CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE received FDA 510(k) clearance on 1986-01-21, under 510(k) number K853091.

Who is the listed applicant for CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE?

The FDA 510(k) record lists Psp Dental Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE?

The FDA product code for CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE is EMA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Psp Dental Co., Ltd. as applicant

K853089SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE K853094EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA K853092PSP C & B TEMP K853090CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO K853093PSP TEMP - TRAY

Related Devices (Code: EMA)

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.