# K990049: CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000

- Pathway: 510(k) (Traditional)
- Applicant: Digident, Ltd.
- Decided: Mar 12, 1999 after 64 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- 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
Longest line of descent: 3 generations back to K884621 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974619: Scanaray/CD-Dent Advanced Computerized X-Ray System, Afp Imaging Corp. (1998) Summary page 1.
- K934949: Digora, Orion Corporation Soredex (1994) Summary page 2.
- K955643: Alara Imaging System, Denoptix, Inc. (1996) Summary page 2.

## Indications for use
The CD-Dent Digital-Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images

Source page: https://510kreport.com/device/K990049
Methodology: https://510kreport.com/methodology