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FDA 510(k)

PEAK Z

K-Number: K131357 · 2013-09-06

ApplicantUltradent Products, Inc.
Decision Date2013-09-06
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PEAK Z 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 2013-09-06 under 510(k) number K131357. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEAK Z?

PEAK Z is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K131357.

When did PEAK Z receive FDA 510(k) clearance?

PEAK Z received FDA 510(k) clearance on 2013-09-06, under 510(k) number K131357.

Who is the listed applicant for PEAK Z?

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 PEAK Z?

The FDA product code for PEAK Z is KLE.

Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: KLE)

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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