Cleared Special

K063558 - PEAK SE

K063558 is the FDA 510(k) clearance for PEAK SE by Ultradent Products, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Special 510(k) pathway after a 17-day FDA review.

K063558 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
17d
Days
Class 2
Risk

K063558 is an FDA 510(k) clearance for the PEAK SE, MODEL 5135. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 14, 2006 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K063558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2006
Decision Date December 14, 2006
Days to Decision 17 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 127d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K063558.
ADHESE ONE
K070646 · Ivoclar Vivadent, Inc. · May 2007
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
K070538 · Dentsply Intl. · Mar 2007
ACE BOND SE
K063780 · Bisco, Inc. · Jan 2007
PEAK BOND, MODEL 5133
K063557 · Ultradent Products, Inc. · Dec 2006
HKBOND 2006
K063062 · Heraeus Kulzer, Inc. · Dec 2006
ADHESIVE DC ACTIVATOR
K062713 · Ivoclar Vivadent, Inc. · Nov 2006