# K021245: Degotzen Synchro

- Pathway: 510(k) (Traditional)
- Applicant: The Gotzen Group, Inc.
- Decided: May 3, 2002 after 14 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Aztech 70: named in the summary without a submission number
- (no number) Gendex Gx770: named in the summary without a submission number
- (no number) Sirona Heliodent Vario: named in the summary without a submission number
- (no number) Dent-x image X-70 Plus: named in the summary without a submission number
- (no number) Belmont Belray 096: named in the summary without a submission number

## Indications for use
The de Gotzen “synchro” Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures.

Source page: https://510kreport.com/device/K021245
Methodology: https://510kreport.com/methodology