Cleared Special

Peak Universal Bond

K240743 · Ultradent Products, Inc. · Dental
Mar 2024
Decision
2d
Days
Class 2
Risk

About This 510(k) Submission

K240743 is an FDA 510(k) clearance for the Peak Universal Bond, 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 March 20, 2024, 2 days after receiving the submission on March 18, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K240743 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2024
Decision Date March 20, 2024
Days to Decision 2 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200