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FDA 510(k)

PEAK SE, MODEL 5135

K-Number: K063558 · 2006-12-14

ApplicantUltradent Products, Inc.
Decision Date2006-12-14
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PEAK SE, MODEL 5135 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 2006-12-14 under 510(k) number K063558. 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 SE, MODEL 5135?

PEAK SE, MODEL 5135 is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K063558.

When did PEAK SE, MODEL 5135 receive FDA 510(k) clearance?

PEAK SE, MODEL 5135 received FDA 510(k) clearance on 2006-12-14, under 510(k) number K063558.

Who is the listed applicant for PEAK SE, MODEL 5135?

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 SE, MODEL 5135?

The FDA product code for PEAK SE, MODEL 5135 is KLE.

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Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: KLE)

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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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