FDA 510(k)

Vista BC Sealer

K-Number: K221811 · 2022-11-21

Decision Date2022-11-21

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Vista BC Sealer is a medical device manufactured by Inter-Med, Inc.. It received FDA 510(k) clearance on 2022-11-21 under approval number K221811. 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 Vista BC Sealer?

Vista BC Sealer is a medical device that received FDA 510(k) clearance on 2022-11-21. It is manufactured by Inter-Med, Inc.. The 510(k) number is K221811.

When was Vista BC Sealer approved by the FDA?

Vista BC Sealer received FDA 510(k) clearance on 2022-11-21, under approval number K221811.

What company makes Vista BC Sealer?

Vista BC Sealer is manufactured by Inter-Med, Inc..

What is the FDA product code for Vista BC Sealer?

The FDA product code for Vista BC Sealer is KIF.

Other Devices by Inter-Med, Inc.

K211721PS System K241457Vista BC Putty K241354Sealer Solvent K241489ReminGel K253337REGEN Bioactive Cement

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.