Cleared Traditional

Bond-PR? Universal Adhesive

K260682 · Premier Dental Products Company · Dental

Mar 2026

Decision

Days

Class 2

Risk

About This 510(k) Submission

K260682 is an FDA 510(k) clearance for the Bond-PR? Universal Adhesive, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Premier Dental Products Company (Plymouth Meeting, US). The FDA issued a Cleared decision on March 3, 2026, 1 days after receiving the submission on March 2, 2026. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K260682 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2026
Decision Date	March 03, 2026
Days to Decision	1 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF