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
K935122Substantially Equivalent

Dentaurum Metal Brackets

Dentauraum, Inc., Newtown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935122 is the FDA 510(k) clearance record for DENTAURUM METAL BRACKETS, a class I device, cleared for Dentauraum, Inc. on under FDA product code EJF (Bracket, Metal, Orthodontic). FDA records list 24 510(k) clearances for Dentauraum, Inc., from to . As of , FDA records show no recalls naming K935122.

Clearance record

Decision date
Received
(95 days to decision)
Product code
EJF Bracket, Metal, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Dentauraum, Inc. 10 Pheasant Run, Newtown PA
510(k) summary
Statement
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