Product code DZK— Dental

ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E

Classification name
Wire, Fixation, Intraosseous
Device class
Class 2
Regulation
21 CFR 872.4880
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

Market context for product code DZK

FDA has cleared 2 devices under product code DZK between 2002 and 2010, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code DZK

Recent clearances under product code DZK

Data sourced from openFDA. This site is unofficial and independent of the FDA.