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FDA 510(k)

PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT

K-Number: K082115 · 2009-01-15

ApplicantS & C Polymer GmbH
Decision Date2009-01-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT 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 2009-01-15 under 510(k) number K082115. 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 PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT?

PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT is a medical device that received FDA 510(k) clearance on 2009-01-15. The listed applicant is S & C Polymer GmbH. The 510(k) number is K082115.

When did PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT receive FDA 510(k) clearance?

PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT received FDA 510(k) clearance on 2009-01-15, under 510(k) number K082115.

Who is the listed applicant for PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT?

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 PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT?

The FDA product code for PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT is EMA.

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Other records listing S & C Polymer GmbH as applicant

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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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