510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932675Substantially Equivalent

Gxp Dental X-Ray Processor

Gendex Corp., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932675 is the FDA 510(k) clearance record for GXP DENTAL X-RAY PROCESSOR, a class I device, cleared for Gendex Corp. on under FDA product code EGN (Scissors, Surgical Tissue, Dental). FDA records list 16 510(k) clearances for Gendex Corp., from to . As of , FDA records show no recalls naming K932675.

Clearance record

Decision date
Received
(54 days to decision)
Product code
EGN Scissors, Surgical Tissue, Dental
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Gendex Corp. 901 W. Oakton St., Des Plaines IL
510(k) summary
Statement
Third party review
No

Clearances, product code EGN

Trailing 12 months

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

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