FDA 510(k)

EDS Bioceramic Sealer (Bioseal)

K-Number: K202281 · 2021-02-12

Decision Date2021-02-12

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EDS Bioceramic Sealer (Bioseal) is a medical device manufactured by Essential Dental Systems. It received FDA 510(k) clearance on 2021-02-12 under approval number K202281. 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 EDS Bioceramic Sealer (Bioseal)?

EDS Bioceramic Sealer (Bioseal) is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by Essential Dental Systems. The 510(k) number is K202281.

When was EDS Bioceramic Sealer (Bioseal) approved by the FDA?

EDS Bioceramic Sealer (Bioseal) received FDA 510(k) clearance on 2021-02-12, under approval number K202281.

What company makes EDS Bioceramic Sealer (Bioseal)?

EDS Bioceramic Sealer (Bioseal) is manufactured by Essential Dental Systems.

What is the FDA product code for EDS Bioceramic Sealer (Bioseal)?

The FDA product code for EDS Bioceramic Sealer (Bioseal) is KIF.

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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.