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FDA 510(k)

Vista BC Sealer

K-Number: K221811 · 2022-11-21

ApplicantInter-Med, Inc.
Decision Date2022-11-21
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vista BC Sealer is the device name listed in this FDA 510(k) record. The listed applicant is Inter-Med, Inc.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) 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. The listed applicant is Inter-Med, Inc.. The 510(k) number is K221811.

When did Vista BC Sealer receive FDA 510(k) clearance?

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

Who is the listed applicant for Vista BC Sealer?

The FDA 510(k) record lists Inter-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vista BC Sealer?

The FDA product code for Vista BC Sealer is KIF.

Other records listing Inter-Med, Inc. as applicant

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.

K253337REGEN Bioactive CementK241489ReminGelK241457Vista BC PuttyK241354Sealer SolventK211721PS System

Related Devices (Code: KIF)

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.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

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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