Cleared Traditional

PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)

K100752 · Ultradent Products, Inc. · Dental

Jul 2010

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K100752 is an FDA 510(k) clearance for the PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE), a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 16, 2010, 121 days after receiving the submission on March 17, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K100752 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2010
Decision Date	July 16, 2010
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF