FDA 510(k)

ENDOSOLV

K-Number: K172839 · 2018-02-13

Decision Date2018-02-13

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ENDOSOLV is a medical device manufactured by Septodont. It received FDA 510(k) clearance on 2018-02-13 under approval number K172839. 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 ENDOSOLV?

ENDOSOLV is a medical device that received FDA 510(k) clearance on 2018-02-13. It is manufactured by Septodont. The 510(k) number is K172839.

When was ENDOSOLV approved by the FDA?

ENDOSOLV received FDA 510(k) clearance on 2018-02-13, under approval number K172839.

What company makes ENDOSOLV?

ENDOSOLV is manufactured by Septodont.

What is the FDA product code for ENDOSOLV?

The FDA product code for ENDOSOLV is KIF.

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Other Devices by Septodont

K212283BioRoot Flow 0.5g, BioRoot Flow 2g K211799Biodentine XP 500, Biodentine XP 200

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.