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FDA 510(k)

CARBOXYLATE CEM, PHOSPHATE CEM

K-Number: K081702 · 2008-09-05

ApplicantS & C Polymer GmbH
Decision Date2008-09-05
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARBOXYLATE CEM, PHOSPHATE CEM is the device name listed in this FDA 510(k) record. The listed applicant is S & C Polymer GmbH. It received FDA 510(k) clearance on 2008-09-05 under 510(k) number K081702. 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 CARBOXYLATE CEM, PHOSPHATE CEM?

CARBOXYLATE CEM, PHOSPHATE CEM is a medical device that received FDA 510(k) clearance on 2008-09-05. The listed applicant is S & C Polymer GmbH. The 510(k) number is K081702.

When did CARBOXYLATE CEM, PHOSPHATE CEM receive FDA 510(k) clearance?

CARBOXYLATE CEM, PHOSPHATE CEM received FDA 510(k) clearance on 2008-09-05, under 510(k) number K081702.

Who is the listed applicant for CARBOXYLATE CEM, PHOSPHATE CEM?

The FDA 510(k) record lists S & C Polymer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARBOXYLATE CEM, PHOSPHATE CEM?

The FDA product code for CARBOXYLATE CEM, PHOSPHATE CEM is EMA.

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Other records listing S & C Polymer GmbH as applicant

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.

K091735DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANTK083062ROOT CANAL XRK083766PHOGLASS CEMK082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTK042614S&C-SELF ETCH PR-BONDK031420S & C -BRACKET ADHESIVES

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-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.

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