JELENKO PORCELAIN SYSTEM PVS PROCELAIN— 510(k) K923717

Name: FDA 510(k) clearance K923717
Creator: U.S. Food and Drug Administration
Published: 1993-03-16

Substantially Equivalent

J.F. Jelenko & Co., Inc.

FDA 510(k) clearance K923717 for JELENKO PORCELAIN SYSTEM PVS PROCELAIN, Substantially Equivalent on 1993-03-16. Applicant: J.F. Jelenko & Co., Inc.. Device class: 2.

Clearance details

Applicant: J.F. Jelenko & Co., Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 1992-07-27
Decision date: 1993-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

view all

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 J.F. Jelenko & Co., Inc.

view all

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