ENAMIC— 510(k) K122269

Substantially Equivalent

Vita Zahnfabrik H.Rauter GmbH & Co.

FDA 510(k) clearance K122269 for ENAMIC, Substantially Equivalent on 2012-12-13. Applicant: Vita Zahnfabrik H.Rauter GmbH & Co.. Device class: 2.

Clearance details

Applicant: Vita Zahnfabrik H.Rauter GmbH & Co.
Product code: Product code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2012-07-30
Decision date: 2012-12-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Vita Zahnfabrik H.Rauter GmbH & Co.

K243940 — VITA YZ Multi Translucent2025-02-21
K180703 — VITA YZ ST and VITA YZ XT2018-08-01
K153645 — VITA ENAMIC Implant Solutions (IS)2016-06-30
K152373 — VITA VM LC Flow2015-12-30
K132070 — VITA SUPRINITY(R)2014-01-31

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