FDA 510(k)

Bright MTA Sealer Plus

K-Number: K231480 · 2023-07-28

Decision Date2023-07-28

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Bright MTA Sealer Plus is a medical device manufactured by Genoss Co., Ltd.. It received FDA 510(k) clearance on 2023-07-28 under approval number K231480. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bright MTA Sealer Plus?

Bright MTA Sealer Plus is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Genoss Co., Ltd.. The 510(k) number is K231480.

When was Bright MTA Sealer Plus approved by the FDA?

Bright MTA Sealer Plus received FDA 510(k) clearance on 2023-07-28, under approval number K231480.

What company makes Bright MTA Sealer Plus?

Bright MTA Sealer Plus is manufactured by Genoss Co., Ltd..

What is the FDA product code for Bright MTA Sealer Plus?

The FDA product code for Bright MTA Sealer Plus is KIF.

Other Devices by Genoss Co., Ltd.

K160079rainbow Shine K153676OSTEON III K160144rainbow LS Block K170596TN-Brush K200155Bright High Flow K200153Bright Bond Universal

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Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom Co., Ltd.

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.