FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT— 510(k) K890608

Name: FDA 510(k) clearance K890608
Creator: U.S. Food and Drug Administration
Published: 1989-04-17

Substantially Equivalent

Macrochem Corp.

FDA 510(k) clearance K890608 for FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT, Substantially Equivalent on 1989-04-17. Applicant: Macrochem Corp.. Device class: 2.

Clearance details

Applicant: Macrochem Corp.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1989-02-06
Decision date: 1989-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, 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 Macrochem Corp.

view all

K890623 — FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT1989-04-17
K890494 — FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS1989-03-29
K880562 — ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT1988-08-19
K861546 — REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT1986-05-21

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