ELASTOMERIC SLEEP APPLIANCE— 510(k) K946112

Name: FDA 510(k) clearance K946112
Creator: U.S. Food and Drug Administration
Published: 1995-06-14

Substantially Equivalent

Village Park Orthodontics

FDA 510(k) clearance K946112 for ELASTOMERIC SLEEP APPLIANCE, Substantially Equivalent on 1995-06-14. Applicant: Village Park Orthodontics. Device class: 2.

Clearance details

Applicant: Village Park Orthodontics
Product code: Code LQZ
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 1994-12-15
Decision date: 1995-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Depew, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQZ

view all

K233754 — AIO Breathe2024-02-23
K230532 — RADx Intraoral Appliance for Snoring and Sleep Apnea2023-07-12
K203712 — The Slide2021-07-20
K191320 — Slow Wave DS82020-10-02
K192581 — The NightBlocks Appliance2020-01-28

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