Cleared Traditional

PacBond One

K210186 · Pac-Dent, Inc. · Dental
Jul 2021
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K210186 is an FDA 510(k) clearance for the PacBond One, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on July 16, 2021, 172 days after receiving the submission on January 25, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K210186 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2021
Decision Date July 16, 2021
Days to Decision 172 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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