# K183121: Qraypen

- Pathway: 510(k) (Traditional)
- Applicant: AIOBIO Co., Ltd.
- Decided: Jul 18, 2019 after 251 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963778 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963778: CDR-Cam, Schick Technologies, Inc. (1996) Summary page 4.

## Indications for use
Qraypen is to be used as an intraoral video source and is indicated for individuals who may benefit from the addition of video images in intraoral dental examinations.

Source page: https://510kreport.com/device/K183121
Methodology: https://510kreport.com/methodology