510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K040556Substantially Equivalent

Trophypan C with Orthoimaging/omsimaging Accessory

Eastman Kodak Company, Rochester NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040556 is the FDA 510(k) clearance record for TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY, a class II device, cleared for Eastman Kodak Company on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 291 510(k) clearances for Eastman Kodak Company, from to . As of , FDA records show no recalls naming K040556.

Clearance record

Decision date
Received
(36 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
Eastman Kodak Company 343 State St., Rochester NY
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 November 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EHD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20262
March 20262
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260