510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K872825Substantially Equivalent

Axial Tome, 60, Fluoro and Tomax

Axialtome Corp., San Carlos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872825 is the FDA 510(k) clearance record for AXIAL TOME, 60, FLUORO AND TOMAX, a class II device, cleared for Axialtome Corp. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list one 510(k) clearance for Axialtome Corp. As of , FDA records show no recalls naming K872825.

Clearance record

Decision date
Received
(259 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
Axialtome Corp. 1095-A Industrial Rd., San Carlos CA
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