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FDA 510(k)

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)

K-Number: K242934 · 2024-12-12

ApplicantLongly Biotechnology (Wuhan) Co., Ltd.
Decision Date2024-12-12
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) is the device name listed in this FDA 510(k) record. The listed applicant is Longly Biotechnology (Wuhan) Co., Ltd.. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K242934. 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 Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)?

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Longly Biotechnology (Wuhan) Co., Ltd.. The 510(k) number is K242934.

When did Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) receive FDA 510(k) clearance?

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) received FDA 510(k) clearance on 2024-12-12, under 510(k) number K242934.

Who is the listed applicant for Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)?

The FDA 510(k) record lists Longly Biotechnology (Wuhan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)?

The FDA product code for Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) is KIF.

Related Clinical Trials

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.

NCT04945993Tooth Retention After Root Canal Treatment With Endomethasone NACTIVE_NOT_RECRUITINGNCT07246512A Comparative Analysis of Biomaterials for Retrograde Filling in Apical Surgery.COMPLETEDNCT07388901In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal SealersRECRUITINGNCT07526844Effect of Instrumentation Systems and Sealers on Postoperative PainNOT_YET_RECRUITINGNCT07608939Postoperative Pain After Root Canal Treatment Using Different Root Canal SealersNOT_YET_RECRUITINGNCT07642284Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone ProtocolsNOT_YET_RECRUITING

Other records listing Longly Biotechnology (Wuhan) Co., Ltd. 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.

K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)

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.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

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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