Well-Root PT
K-Number: K252285 · 2025-09-19
ApplicantVericom Co., Ltd.
Decision Date2025-09-19
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Well-Root PT is a medical device manufactured by Vericom Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under approval number K252285. 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 Well-Root PT?
Well-Root PT is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Vericom Co., Ltd.. The 510(k) number is K252285.
When was Well-Root PT approved by the FDA?
Well-Root PT received FDA 510(k) clearance on 2025-09-19, under approval number K252285.
What company makes Well-Root PT?
Well-Root PT is manufactured by Vericom Co., Ltd..
What is the FDA product code for Well-Root PT?
The FDA product code for Well-Root PT is KIF.
Other Devices by Vericom Co., Ltd.
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.