510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041718Substantially Equivalent

Keles Facemask

Great Lakes Orthodontics, Ltd., Tonawanda NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041718 is the FDA 510(k) clearance record for KELES FACEMASK, a class II device, cleared for Great Lakes Orthodontics, Ltd. on under FDA product code DZB (Headgear, Extraoral, Orthodontic). FDA records list 13 510(k) clearances for Great Lakes Orthodontics, Ltd., from to . As of , FDA records show no recalls naming K041718.

Clearance record

Decision date
Received
(113 days to decision)
Product code
DZB Headgear, Extraoral, Orthodontic
Regulation
21 CFR 872.5500
Device class
Class II
Review panel
Dental
Applicant
Great Lakes Orthodontics, Ltd. 200 Cooper Ave., Tonawanda NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZB

Trailing 12 months

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

FDA records show no clearances under product code DZB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZB, 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