CERAMIX PORCELAIN SYSTEM— 510(k) K000983

Substantially Equivalent

C-Mix

FDA 510(k) clearance K000983 for CERAMIX PORCELAIN SYSTEM, Substantially Equivalent on 2000-08-26. Applicant: C-Mix. Device class: 2.

Clearance details

Applicant: C-Mix
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2000-03-27
Decision date: 2000-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Port Riche, FL, 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 C-Mix

K000981 — CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX2000-06-13

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