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FDA 510(k)

ROOT CANAL FILLING RESIN

K-Number: K854253 · 1985-12-16

ApplicantDentsply Intl.
Decision Date1985-12-16
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOT CANAL FILLING RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1985-12-16 under 510(k) number K854253. 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 ROOT CANAL FILLING RESIN?

ROOT CANAL FILLING RESIN is a medical device that received FDA 510(k) clearance on 1985-12-16. The listed applicant is Dentsply Intl.. The 510(k) number is K854253.

When did ROOT CANAL FILLING RESIN receive FDA 510(k) clearance?

ROOT CANAL FILLING RESIN received FDA 510(k) clearance on 1985-12-16, under 510(k) number K854253.

Who is the listed applicant for ROOT CANAL FILLING RESIN?

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

What is the FDA product code for ROOT CANAL FILLING RESIN?

The FDA product code for ROOT CANAL FILLING RESIN is KIF.

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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

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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