510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K053172Substantially Equivalent

Universal-X (USA) or /Krystal-X (Europe)

Owandy SAS, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053172 is the FDA 510(k) clearance record for UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE), a class II device, cleared for Owandy Sas on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list one 510(k) clearance for Owandy Sas. As of , FDA records show no recalls naming K053172.

Clearance record

Decision date
Received
(207 days to decision)
Product code
MUH System, X-Ray, Extraoral Source, Digital
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Owandy Sas 1251 Ave. Of The Americas, New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUH

Trailing 12 months
3 clearances under product code MUH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260