Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Biodentine XP 500, Biodentine XP 200

K-Number: K211799 · 2021-08-10

ApplicantSeptodont
Decision Date2021-08-10
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Biodentine XP 500, Biodentine XP 200 is a medical device manufactured by Septodont. It received FDA 510(k) clearance on 2021-08-10 under approval number K211799. 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 XP 500, Biodentine XP 200?

Biodentine XP 500, Biodentine XP 200 is a medical device that received FDA 510(k) clearance on 2021-08-10. It is manufactured by Septodont. The 510(k) number is K211799.

When was Biodentine XP 500, Biodentine XP 200 approved by the FDA?

Biodentine XP 500, Biodentine XP 200 received FDA 510(k) clearance on 2021-08-10, under approval number K211799.

What company makes Biodentine XP 500, Biodentine XP 200?

Biodentine XP 500, Biodentine XP 200 is manufactured by Septodont.

What is the FDA product code for Biodentine XP 500, Biodentine XP 200?

The FDA product code for Biodentine XP 500, Biodentine XP 200 is KIF.

Related Clinical Trials

NCT05536115 Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket COMPLETED NCT04945993 Tooth Retention After Root Canal Treatment With Endomethasone N ACTIVE_NOT_RECRUITING

Other Devices by Septodont

K172839ENDOSOLV K212283BioRoot Flow 0.5g, BioRoot Flow 2g

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.

↑