UltraCal XS
K-Number: K211905 · 2021-10-13
ApplicantUltradent Products, Inc.
Decision Date2021-10-13
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
UltraCal XS is a medical device manufactured by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2021-10-13 under approval number K211905. 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 UltraCal XS?
UltraCal XS is a medical device that received FDA 510(k) clearance on 2021-10-13. It is manufactured by Ultradent Products, Inc.. The 510(k) number is K211905.
When was UltraCal XS approved by the FDA?
UltraCal XS received FDA 510(k) clearance on 2021-10-13, under approval number K211905.
What company makes UltraCal XS?
UltraCal XS is manufactured by Ultradent Products, Inc..
What is the FDA product code for UltraCal XS?
The FDA product code for UltraCal XS is KIF.
Other Devices by Ultradent Products, Inc.
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.