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FDA 510(k)

GILB-2, GLASS IONOMER PROTECTIVE COATING

K-Number: K073395 · 2008-01-17

Applicant3M Espe Dental Products
Decision Date2008-01-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GILB-2, GLASS IONOMER PROTECTIVE COATING is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2008-01-17 under 510(k) number K073395. 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 GILB-2, GLASS IONOMER PROTECTIVE COATING?

GILB-2, GLASS IONOMER PROTECTIVE COATING is a medical device that received FDA 510(k) clearance on 2008-01-17. The listed applicant is 3M Espe Dental Products. The 510(k) number is K073395.

When did GILB-2, GLASS IONOMER PROTECTIVE COATING receive FDA 510(k) clearance?

GILB-2, GLASS IONOMER PROTECTIVE COATING received FDA 510(k) clearance on 2008-01-17, under 510(k) number K073395.

Who is the listed applicant for GILB-2, GLASS IONOMER PROTECTIVE COATING?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GILB-2, GLASS IONOMER PROTECTIVE COATING?

The FDA product code for GILB-2, GLASS IONOMER PROTECTIVE COATING is EMA.

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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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