VITA ENAMIC STAINS— 510(k) K123761

Substantially Equivalent

Innovation Meditech GmbH

FDA 510(k) clearance K123761 for VITA ENAMIC STAINS, Substantially Equivalent on 2013-03-01. Applicant: Innovation Meditech GmbH. Device class: 2.

Clearance details

Applicant: Innovation Meditech GmbH
Product code: Code EBD
Device class: Class 2
Regulation: 21 CFR 872.3310
Advisory panel: Dental
Date received: 2012-12-07
Decision date: 2013-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBD

K254091 — GLOSSY COAT (15ML)2026-04-06
K250804 — ID LIGHT CURE SYSTEM2025-06-04
K240735 — visio.lign color, visio.lign shield2024-12-12
K223365 — RODIN Palette Naturalizing Kit2023-03-27
K211854 — VITA Akzent LC2021-11-22

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