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FDA 510(k)

BIODENTINE

K-Number: K092251 · 2009-10-30

ApplicantSeptodont
Decision Date2009-10-30
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIODENTINE is the device name listed in this FDA 510(k) record. The listed applicant is Septodont. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K092251. 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 BIODENTINE?

BIODENTINE is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Septodont. The 510(k) number is K092251.

When did BIODENTINE receive FDA 510(k) clearance?

BIODENTINE received FDA 510(k) clearance on 2009-10-30, under 510(k) number K092251.

Who is the listed applicant for BIODENTINE?

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

What is the FDA product code for BIODENTINE?

The FDA product code for BIODENTINE is KIF.

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Other records listing Septodont 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.

K212283BioRoot Flow 0.5g, BioRoot Flow 2gK211799Biodentine XP 500, Biodentine XP 200K172839ENDOSOLVK093711RACEGELK063634RTR SYRINGEK051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70

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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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