DZK — Wire, Fixation, Intraosseous Class II

FDA Device Classification

FDA product code DZK covers "Wire, Fixation, Intraosseous", a Class II medical device regulated under 21 CFR 872.4880. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DZK
Device Class
Class II
Regulation Number
872.4880
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K092530russell b. waltherSPRYTIE, MODELS ST001, ST002 AND ST003April 2, 2010
K022821ideatricsARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I000November 15, 2002