ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.— 510(k) K902078

Name: FDA 510(k) clearance K902078
Creator: U.S. Food and Drug Administration
Published: 1990-08-03

Substantially Equivalent

Crx Medical, Inc.

FDA 510(k) clearance K902078 for ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY., Substantially Equivalent on 1990-08-03. Applicant: Crx Medical, Inc.. Device class: 2.

Clearance details

Applicant: Crx Medical, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1990-05-08
Decision date: 1990-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, 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 Crx Medical, Inc.

view all

K884652 — OCTYLDENT1989-05-24

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