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FDA 510(k)

APEXIT ROOT CANAL SEALER

K-Number: K893794 · 1989-11-29

ApplicantWilliams Dental Co., Inc.
Decision Date1989-11-29
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APEXIT ROOT CANAL SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Williams Dental Co., Inc.. It received FDA 510(k) clearance on 1989-11-29 under 510(k) number K893794. 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 APEXIT ROOT CANAL SEALER?

APEXIT ROOT CANAL SEALER is a medical device that received FDA 510(k) clearance on 1989-11-29. The listed applicant is Williams Dental Co., Inc.. The 510(k) number is K893794.

When did APEXIT ROOT CANAL SEALER receive FDA 510(k) clearance?

APEXIT ROOT CANAL SEALER received FDA 510(k) clearance on 1989-11-29, under 510(k) number K893794.

Who is the listed applicant for APEXIT ROOT CANAL SEALER?

The FDA 510(k) record lists Williams Dental Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APEXIT ROOT CANAL SEALER?

The FDA product code for APEXIT ROOT CANAL SEALER is KIF.

Related Clinical Trials

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Other records listing Williams Dental Co., 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.

K884588HELIOMOLAR(R) DENTAL RESTORATIVE

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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