ADHESIVE DC ACTIVATOR— 510(k) K062713

Substantially Equivalent

Ivoclar Vivadent, Inc.

FDA 510(k) clearance K062713 for ADHESIVE DC ACTIVATOR, Substantially Equivalent on 2006-11-02. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2006-09-11
Decision date: 2006-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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 Ivoclar Vivadent, Inc.

K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K253953 — IPS e.max Zirconia2026-03-10
K233995 — Ivotion Base Print2024-02-23
K153753 — TelioCAD Multi2016-04-12
K143575 — Accu-Dent XD Tray, Accu-Dent XD Syringe2015-04-03

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