FDA 510(k)

DIA-ROOT BIO Sealer

K-Number: K200175 · 2020-06-25

Decision Date2020-06-25

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DIA-ROOT BIO Sealer is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2020-06-25 under approval number K200175. 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 DIA-ROOT BIO Sealer?

DIA-ROOT BIO Sealer is a medical device that received FDA 510(k) clearance on 2020-06-25. It is manufactured by DiaDent Group International. The 510(k) number is K200175.

When was DIA-ROOT BIO Sealer approved by the FDA?

DIA-ROOT BIO Sealer received FDA 510(k) clearance on 2020-06-25, under approval number K200175.

What company makes DIA-ROOT BIO Sealer?

DIA-ROOT BIO Sealer is manufactured by DiaDent Group International.

What is the FDA product code for DIA-ROOT BIO Sealer?

The FDA product code for DIA-ROOT BIO Sealer is KIF.

Other Devices by DiaDent Group International

K182009Dia-Proseal K182625Diapex Plus K200174DIA-ROOT BIO MTA K200809D-LUX+ K192392DiaPlus K190091Diapaste

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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.