510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K803316Substantially Equivalent

Orthodontic Bracket

Orec Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803316 is the FDA 510(k) clearance record for ORTHODONTIC BRACKET, a class I device, cleared for Orec Corp. on under FDA product code EJF (Bracket, Metal, Orthodontic). FDA records list 2 510(k) clearances for Orec Corp., from to . As of , FDA records show no recalls naming K803316.

Clearance record

Decision date
Received
(15 days to decision)
Product code
EJF Bracket, Metal, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Orec Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EJF

Trailing 12 months

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

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