J-Temp
K-Number: K221909 · 2022-07-01
ApplicantUltradent Products, Inc.
Decision Date2022-07-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
J-Temp is a medical device manufactured by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2022-07-01 under approval number K221909. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the J-Temp?
J-Temp is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Ultradent Products, Inc.. The 510(k) number is K221909.
When was J-Temp approved by the FDA?
J-Temp received FDA 510(k) clearance on 2022-07-01, under approval number K221909.
What company makes J-Temp?
J-Temp is manufactured by Ultradent Products, Inc..
What is the FDA product code for J-Temp?
The FDA product code for J-Temp is EBF.
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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.