510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032355Substantially Equivalent

Orthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105 0161Ww, 5105 0181Ww

Dentsply Gendex, Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032355 is the FDA 510(k) clearance record for ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW, a class II device, cleared for Dentsply Gendex on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list one 510(k) clearance for Dentsply Gendex. As of , FDA records show one recall naming K032355.

Clearance record

Decision date
Received
(57 days to decision)
Product code
EHD Unit, X-Ray, Extraoral With Timer
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Dentsply Gendex 901 W. Oakton St., Des Plaines IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EHD

Trailing 12 months
6 clearances under product code EHD in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EHD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20262
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260