510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112627Substantially Equivalent

Millenium Anti-Snoring Device

Millenium Dental Laboratory, Inc., Ramsey MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K112627 is the FDA 510(k) clearance record for MILLENIUM ANTI-SNORING DEVICE, a class II device, cleared for Millenium Dental Laboratory, Inc. on under FDA product code LQZ (Device, Jaw Repositioning). FDA records list one 510(k) clearance for Millenium Dental Laboratory, Inc. As of , FDA records show no recalls naming K112627.

Clearance record

Decision date
Received
(271 days to decision)
Product code
LQZ Device, Jaw Repositioning
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Millenium Dental Laboratory, Inc. 18056 Waco Dr. NW, Ramsey MN
510(k) summary
Statement
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