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FDA 510(k)

AH Plus Endodontic Sealer

K-Number: K243546 · 2025-02-13

ApplicantDentsply Sirona, Inc.
Decision Date2025-02-13
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AH Plus Endodontic Sealer is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2025-02-13 under approval number K243546. 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 AH Plus Endodontic Sealer?

AH Plus Endodontic Sealer is a medical device that received FDA 510(k) clearance on 2025-02-13. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K243546.

When was AH Plus Endodontic Sealer approved by the FDA?

AH Plus Endodontic Sealer received FDA 510(k) clearance on 2025-02-13, under approval number K243546.

What company makes AH Plus Endodontic Sealer?

AH Plus Endodontic Sealer is manufactured by Dentsply Sirona, Inc..

What is the FDA product code for AH Plus Endodontic Sealer?

The FDA product code for AH Plus Endodontic Sealer is KIF.

Related Clinical Trials

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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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