FUTURA GLASS IONOMER SILVER REINFORCED— 510(k) K991974

Name: FDA 510(k) clearance K991974
Creator: U.S. Food and Drug Administration
Published: 1999-09-17

Substantially Equivalent

Ab Ardent

FDA 510(k) clearance K991974 for FUTURA GLASS IONOMER SILVER REINFORCED, Substantially Equivalent on 1999-09-17. Applicant: Ab Ardent. Device class: 2.

Clearance details

Applicant: Ab Ardent
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1999-06-11
Decision date: 1999-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

view all

K254201 — Any-Cem2026-08-13
K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from Ab Ardent

view all

K131753 — MERIDIAN2013-11-14
K040465 — LATIT FLOW2004-07-20
K022971 — MICROHYBRID 112002-11-25
K022972 — MICROFILL 132002-11-22
K022973 — ADHESIVE 142002-11-22

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