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
K935443Substantially Equivalent

Add Line Devices(parts) Electric Handpiece Systems

Osada Electric Co., Ltd., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935443 is the FDA 510(k) clearance record for ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS, a class II device, cleared for Osada Electric Co., Ltd. on under FDA product code DZH (Saw, Bone, Ac-Powered). FDA records list 3 510(k) clearances for Osada Electric Co., Ltd., from to . As of , FDA records show no recalls naming K935443.

Clearance record

Decision date
Received
(312 days to decision)
Product code
DZH Saw, Bone, Ac-Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Osada Electric Co., Ltd. 8242 W. 3rd St., Suite 150, Los Angeles CA
510(k) summary
Statement
Third party review
No

Clearances, product code DZH

Trailing 12 months

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

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