# K992610: Gendex 765DC, Model 110-0154

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 7, 1999 after 34 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sirona Heliodent DS: named in the summary without a submission number
- (no number) Planmeca Prostyle Intra: named in the summary without a submission number
- (no number) Gendex GX-DC: named in the summary without a submission number
- (no number) Gendex GX-770: named in the summary without a submission number

## Most influential descendants
- K043092: Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 (2004), 13 descendants of its own
- K083344: Heliodent Plus (2008), 9 descendants of its own
- K030634: Endos DC (2003), 8 descendants of its own
- K120318: Vivi Ergon-X HF (2012), 7 descendants of its own
- K163519: RX DC (2017), 4 descendants of its own

## Recalls of this device
- Aug 12, 2014 · Class II · Z-0009-2015: Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior t
- Dec 29, 2011 · Not classified · Z-1358-2012: Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.
- Dec 20, 2010 · Not classified · Z-1559-2011: The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.
- Dec 17, 2010 · Not classified · Z-1248-2011: The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.

## Indications for use
The Gendex 765DC Intraoral Dental X-Ray System is to be used as an extraoral source of x-rays in Dental Radiography.

Source page: https://510kreport.com/device/K992610
Methodology: https://510kreport.com/methodology