510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K052840Substantially Equivalent

Igi-System

Denx Advanced Dental Systems, Jerusalem, Al, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052840 is the FDA 510(k) clearance record for IGI-SYSTEM, a class II device, cleared for Denx Advanced Dental Systems on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 2 510(k) clearances for Denx Advanced Dental Systems, from to . As of , FDA records show no recalls naming K052840.

Clearance record

Decision date
Received
(70 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Denx Advanced Dental Systems Moshav Ora 106, Jerusalem, Al, IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HAW

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