GENDEX 765DC, MODEL 110-0154— 510(k) K992610

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K992610 for GENDEX 765DC, MODEL 110-0154, Substantially Equivalent on 1999-09-07. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 1999-08-04
Decision date: 1999-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K992610

K-number listed on FDA's recall record

Z-0009-2015 — eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-rayClass II·Terminated·Gendex Corp·20140812

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992610.

Data sourced from openFDA. This site is unofficial and independent of the FDA.