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FDA 510(k)

PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)

K-Number: K101869 · 2010-09-29

ApplicantSilmet , Ltd.
Decision Date2010-09-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) is the device name listed in this FDA 510(k) record. The listed applicant is Silmet , Ltd.. It received FDA 510(k) clearance on 2010-09-29 under 510(k) number K101869. 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 PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)?

PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) is a medical device that received FDA 510(k) clearance on 2010-09-29. The listed applicant is Silmet , Ltd.. The 510(k) number is K101869.

When did PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) receive FDA 510(k) clearance?

PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) received FDA 510(k) clearance on 2010-09-29, under 510(k) number K101869.

Who is the listed applicant for PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)?

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

What is the FDA product code for PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)?

The FDA product code for PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) is EMA.

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Other records listing Silmet , Ltd. 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.

K110403PROLINK ADHESIVES (PROLINK, PROLINK SE)K103190PROFIL COMPOSITES (PROFIL, PROFIL FLOW)

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

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

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