510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093105Substantially Equivalent

Visteo

Owandy Inc., Roswell GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093105 is the FDA 510(k) clearance record for VISTEO, a class II device, cleared for Owandy on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 6 510(k) clearances for Owandy, from to . As of , FDA records show no recalls naming K093105.

Clearance record

Decision date
Received
(382 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
Owandy 845 Aronson Lake Ct., Roswell GA
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