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FDA 510(k)

LEE ENDOFILL, ROOT CANAL FILLING RESIN

K-Number: K810923 · 1981-04-21

ApplicantLee Pharmaceuticals
Decision Date1981-04-21
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEE ENDOFILL, ROOT CANAL FILLING RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1981-04-21 under 510(k) number K810923. 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 LEE ENDOFILL, ROOT CANAL FILLING RESIN?

LEE ENDOFILL, ROOT CANAL FILLING RESIN is a medical device that received FDA 510(k) clearance on 1981-04-21. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K810923.

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

LEE ENDOFILL, ROOT CANAL FILLING RESIN received FDA 510(k) clearance on 1981-04-21, under 510(k) number K810923.

Who is the listed applicant for LEE ENDOFILL, ROOT CANAL FILLING RESIN?

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

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

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

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Other records listing Lee Pharmaceuticals 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.

K924378RESTOBOND 4K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERTK900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSK894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTK881903PROSTHODENT VLK873123LEE COMPOSITE INLAY SYSTEM

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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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