510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896219Substantially Equivalent

Safe-T-Cap Needle Cover

Ausmedics Pty, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896219 is the FDA 510(k) clearance record for SAFE-T-CAP NEEDLE COVER, a class I device, cleared for Ausmedics Pty , Ltd. on under FDA product code DZM (Needle, Dental). FDA records list 2 510(k) clearances for Ausmedics Pty , Ltd., from to . As of , FDA records show no recalls naming K896219.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DZM Needle, Dental
Regulation
21 CFR 872.4730
Device class
Class I
Review panel
Dental
Applicant
Ausmedics Pty , Ltd. 1120 G. St. NW, Washington DC
Third party review
No

Clearances, product code DZM

Trailing 12 months

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

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