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FDA 510(k)

FR ROOT CANAL FILLER

K-Number: K830763 · 1983-08-26

ApplicantShizai Corp.
Decision Date1983-08-26
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FR ROOT CANAL FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Shizai Corp.. It received FDA 510(k) clearance on 1983-08-26 under 510(k) number K830763. 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 FR ROOT CANAL FILLER?

FR ROOT CANAL FILLER is a medical device that received FDA 510(k) clearance on 1983-08-26. The listed applicant is Shizai Corp.. The 510(k) number is K830763.

When did FR ROOT CANAL FILLER receive FDA 510(k) clearance?

FR ROOT CANAL FILLER received FDA 510(k) clearance on 1983-08-26, under 510(k) number K830763.

Who is the listed applicant for FR ROOT CANAL FILLER?

The FDA 510(k) record lists Shizai Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FR ROOT CANAL FILLER?

The FDA product code for FR ROOT CANAL FILLER is KIF.

Related Clinical Trials

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.

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Other records listing Shizai Corp. 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.

K830764FR ROOT CANAL SEALER

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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.

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