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FDA 510(k)

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

K-Number: K240304 · 2024-05-28

ApplicantEnpuno Biotechnology Co., Ltd.
Decision Date2024-05-28
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) is a medical device manufactured by Enpuno Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-28 under approval number K240304. 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 Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)?

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) is a medical device that received FDA 510(k) clearance on 2024-05-28. It is manufactured by Enpuno Biotechnology Co., Ltd.. The 510(k) number is K240304.

When was Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) approved by the FDA?

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) received FDA 510(k) clearance on 2024-05-28, under approval number K240304.

What company makes Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)?

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) is manufactured by Enpuno Biotechnology Co., Ltd..

What is the FDA product code for Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)?

The FDA product code for Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) is KIF.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT05714384 Calcium Silicate Sealer-based Obturation in Root Canal Retreatment COMPLETED NCT04757753 Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial ACTIVE_NOT_RECRUITING NCT04945993 Tooth Retention After Root Canal Treatment With Endomethasone N ACTIVE_NOT_RECRUITING NCT04885686 Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP) COMPLETED NCT07526844 Effect of Instrumentation Systems and Sealers on Postoperative Pain NOT_YET_RECRUITING

Other Devices by Enpuno Biotechnology Co., Ltd.

K251465Root canal repair materials (nRoot BP)

Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom 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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