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FDA 510(k)

ACROSEAL ROOT CANAL OR APICAL SEALER

K-Number: K023976 · 2003-01-30

ApplicantSeptodont S.A.S.
Decision Date2003-01-30
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACROSEAL ROOT CANAL OR APICAL SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Septodont S.A.S.. It received FDA 510(k) clearance on 2003-01-30 under 510(k) number K023976. 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 ACROSEAL ROOT CANAL OR APICAL SEALER?

ACROSEAL ROOT CANAL OR APICAL SEALER is a medical device that received FDA 510(k) clearance on 2003-01-30. The listed applicant is Septodont S.A.S.. The 510(k) number is K023976.

When did ACROSEAL ROOT CANAL OR APICAL SEALER receive FDA 510(k) clearance?

ACROSEAL ROOT CANAL OR APICAL SEALER received FDA 510(k) clearance on 2003-01-30, under 510(k) number K023976.

Who is the listed applicant for ACROSEAL ROOT CANAL OR APICAL SEALER?

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

What is the FDA product code for ACROSEAL ROOT CANAL OR APICAL SEALER?

The FDA product code for ACROSEAL ROOT CANAL OR APICAL SEALER 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

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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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