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FDA 510(k)

UltraTemp Rez II

K-Number: K211237 · 2021-07-13

ApplicantUltradent Products, Inc.
Decision Date2021-07-13
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UltraTemp Rez II 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 2021-07-13 under 510(k) number K211237. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraTemp Rez II?

UltraTemp Rez II is a medical device that received FDA 510(k) clearance on 2021-07-13. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K211237.

When did UltraTemp Rez II receive FDA 510(k) clearance?

UltraTemp Rez II received FDA 510(k) clearance on 2021-07-13, under 510(k) number K211237.

Who is the listed applicant for UltraTemp Rez II?

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 UltraTemp Rez II?

The FDA product code for UltraTemp Rez II is EMA.

Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: EMA)

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.

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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.

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