510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132378Substantially Equivalent

X-Mind Unity

De Gotzen S.r.l., Olgiate Olona, Varese, IT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132378 is the FDA 510(k) clearance record for X-MIND UNITY, a class II device, cleared for De Gotzen S.R.L. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 7 510(k) clearances for De Gotzen S.R.L., from to . As of , FDA records show no recalls naming K132378.

Clearance record

Decision date
Received
(303 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
De Gotzen S.R.L. Via Roma 45, Olgiate Olona, Varese, IT
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