510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854467Substantially Equivalent

S.t.p.b Soft Tissues Protectives Blades

Nortex USA, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854467 is the FDA 510(k) clearance record for S.T.P.B SOFT TISSUES PROTECTIVES BLADES, a class I device, cleared for Nortex USA, Inc. on under FDA product code EEJ (Guard, Disk). FDA records list one 510(k) clearance for Nortex USA, Inc. As of , FDA records show no recalls naming K854467.

Clearance record

Decision date
Received
(126 days to decision)
Product code
EEJ Guard, Disk
Regulation
21 CFR 872.6010
Device class
Class I
Review panel
Dental
Applicant
Nortex USA, Inc. 1032 31st. St. NW, Washington DC
Third party review
No

Clearances, product code EEJ

Trailing 12 months

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

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