HYDRO-CAST ACRYLIC VARNISH, MODEL 78125— 510(k) K991161

Name: FDA 510(k) clearance K991161
Creator: U.S. Food and Drug Administration
Published: 1999-04-29

Substantially Equivalent

Kay See Dental Mfg. Co.

FDA 510(k) clearance K991161 for HYDRO-CAST ACRYLIC VARNISH, MODEL 78125, Substantially Equivalent on 1999-04-29. Applicant: Kay See Dental Mfg. Co.. Device class: 1.

Clearance details

Applicant: Kay See Dental Mfg. Co.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1999-04-07
Decision date: 1999-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIA

view all

K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)2026-08-07
K251626 — Midmark Dental Delivery System2025-11-03
K251491 — K5 Cart, K5 Mount, K5 Swing2025-07-17
K243130 — Integral Dental Unit2025-06-27
K242611 — Integral Dental Units2025-05-27

More clearances from Kay See Dental Mfg. Co.

view all

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