510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843344Substantially Equivalent

Active Vertical Corrector Active Bite

Active Vertical Correctors, Inc., Fort Wayne IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843344 is the FDA 510(k) clearance record for ACTIVE VERTICAL CORRECTOR ACTIVE BITE, a class I device, cleared for Active Vertical Correctors, Inc. on under FDA product code ECO (Spring, Orthodontic). FDA records list 2 510(k) clearances for Active Vertical Correctors, Inc., from to . As of , FDA records show no recalls naming K843344.

Clearance record

Decision date
Received
(98 days to decision)
Product code
ECO Spring, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Active Vertical Correctors, Inc. 4618 E State Blvd. Suite 375, Fort Wayne IN
Third party review
No

Clearances, product code ECO

Trailing 12 months

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

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