Monobond Etch & Prime— 510(k) K150164

Substantially Equivalent

Ivoclar Vivadent, AG

FDA 510(k) clearance K150164 for Monobond Etch & Prime, Substantially Equivalent on 2015-04-03. Applicant: Ivoclar Vivadent, AG. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, AG
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2015-01-26
Decision date: 2015-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaan, LI

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, AG

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K191453 — Cervitec F2020-02-11
K191448 — Barrier Sleeves2019-10-08

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