510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840805Substantially Equivalent

Oral Safe

Great Lakes Orthodontics, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840805 is the FDA 510(k) clearance record for ORAL SAFE, a class I device, cleared for Great Lakes Orthodontics, Ltd. on under FDA product code JER (Cleaner, Denture, Mechanical). FDA records list 13 510(k) clearances for Great Lakes Orthodontics, Ltd., from to . As of , FDA records show no recalls naming K840805.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JER Cleaner, Denture, Mechanical
Regulation
21 CFR 872.3530
Device class
Class I
Review panel
Dental
Applicant
Great Lakes Orthodontics, Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JER

Trailing 12 months

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

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