ORAL SAFE— 510(k) K840805

Substantially Equivalent

Great Lakes Orthodontics, Ltd.

FDA 510(k) clearance K840805 for ORAL SAFE, Substantially Equivalent on 1984-03-30. Applicant: Great Lakes Orthodontics, Ltd.. Device class: 1.

Clearance details

Applicant: Great Lakes Orthodontics, Ltd.
Product code: Code JER
Device class: Class 1
Regulation: 21 CFR 872.3530
Advisory panel: Dental
Date received: 1984-02-24
Decision date: 1984-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JER

K883403 — DENTA PLUS1988-10-25
K881391 — ULTRASONIC DENTURE CLEANER1988-08-26
K872521 — DENTURE CLEANSERS1987-08-11
K852906 — DURACLEAN DENTURE CLEANER1985-07-31
K832359 — ORAL SAFE1983-09-26

More clearances from Great Lakes Orthodontics, Ltd.

K172765 — Smart Moves Complete2018-06-01
K150702 — Exceed Tx2016-03-24
K083479 — BIOCRYL X2009-02-27
K041718 — KELES FACEMASK2004-10-15
K040881 — METACRYL2004-05-25

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