510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080738Substantially Equivalent

Dentron Sensor

Dentron Systems, LLC, Ormond Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080738 is the FDA 510(k) clearance record for DENTRON SENSOR, a class II device, cleared for Dentron Systems, LLC on under FDA product code EAP (Unit, X-Ray, Intraoral). FDA records list one 510(k) clearance for Dentron Systems, LLC. As of , FDA records show no recalls naming K080738.

Clearance record

Decision date
Received
(57 days to decision)
Product code
EAP Unit, X-Ray, Intraoral
Regulation
21 CFR 872.1810
Device class
Class II
Review panel
Dental
Applicant
Dentron Systems, LLC 11 E. Granada Blvd., Ormond Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EAP

Trailing 12 months

FDA records hold no clearances under product code EAP in the trailing twelve months.

FDA records show no clearances under product code EAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260