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
K030605Substantially Equivalent

Rapid Imf

Zygomatics, Ltd., London Se3 0ta, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K030605 is the FDA 510(k) clearance record for RAPID IMF, a class II device, cleared for Zygomatics , Ltd. on under FDA product code DYX (Lock, Wire, And Ligature, Intraoral). FDA records list one 510(k) clearance for Zygomatics , Ltd. As of , FDA records show no recalls naming K030605.

Clearance record

Decision date
Received
(122 days to decision)
Product code
DYX Lock, Wire, And Ligature, Intraoral
Regulation
21 CFR 872.4600
Device class
Class II
Review panel
Dental
Applicant
Zygomatics , Ltd. 20a Montpelier Vale, London Se3 0ta, GB
510(k) summary
Statement
Third party review
No

Clearances, product code DYX

Trailing 12 months

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

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