510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K803291Substantially Equivalent

Artus Drill #2000

JEDMED Instrument Company, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803291 is the FDA 510(k) clearance record for ARTUS DRILL #2000, a class II device, cleared for Jedmed Instrument Co. on under FDA product code DZI (Drill, Bone, Powered). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K803291.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DZI Drill, Bone, Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Jedmed Instrument Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DZI

Trailing 12 months
3 clearances under product code DZI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260