PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR— 510(k) K964525

Name: FDA 510(k) clearance K964525
Creator: U.S. Food and Drug Administration
Published: 1997-01-22

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K964525 for PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR, Substantially Equivalent on 1997-01-22. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1996-11-12
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

view all

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Dentsply Intl.

view all

K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC2013-02-22
K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS2008-03-27
K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE2007-03-14
K070019 — CARRARA VOLUMIA2007-01-26
K061427 — PRE-IMPRESSION CONDITIONING SOLUTION2006-06-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.