Eclipse Kiss Zirconia— 510(k) K163238

Substantially Equivalent

Ams

FDA 510(k) clearance K163238 for Eclipse Kiss Zirconia, Substantially Equivalent on 2017-05-04. Applicant: Ams. Device class: 2.

Clearance details

Applicant: Ams
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2016-11-18
Decision date: 2017-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

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 Ams

K113131 — LIASYS 4502012-03-08

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