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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) 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. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K221909.

When did J-Temp receive FDA 510(k) clearance?

J-Temp received FDA 510(k) clearance on 2022-07-01, under 510(k) number K221909.

Who is the listed applicant for J-Temp?

The FDA 510(k) record lists Ultradent Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for J-Temp?

The FDA product code for J-Temp is EBF.

Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom 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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