510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K043136Substantially Equivalent

Elity 70 X-Ray

Dental X-Ray E.U., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043136 is the FDA 510(k) clearance record for ELITY 70 X-RAY, a class II device, cleared for Dental X-Ray E.U. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list one 510(k) clearance for Dental X-Ray E.U. As of , FDA records show no recalls naming K043136.

Clearance record

Decision date
Received
(55 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
Dental X-Ray E.U. 1460 NW 107 Ave. Suite G, Miami FL
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