510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K946112Substantially Equivalent

Elastomeric Sleep Appliance

Village Park Orthodontics, Depew NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946112 is the FDA 510(k) clearance record for ELASTOMERIC SLEEP APPLIANCE, a class II device, cleared for Village Park Orthodontics on under FDA product code LQZ (Device, Jaw Repositioning). FDA records list one 510(k) clearance for Village Park Orthodontics. As of , FDA records show no recalls naming K946112.

Clearance record

Decision date
Received
(181 days to decision)
Product code
LQZ Device, Jaw Repositioning
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Village Park Orthodontics 16 Suffield Ave., Depew NY
510(k) summary
Summary
Third party review
No

Clearances, product code LQZ

Trailing 12 months

FDA records hold no clearances under product code LQZ in the trailing twelve months.

FDA records show no clearances under product code LQZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260