# K061175: Claris I310D Intraoral Camera System & Accessories

- Pathway: 510(k) (Special)
- Applicant: Sota Precision Optics, Inc.
- Decided: May 23, 2006 after 26 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: 2 generations back to K981663 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032341: Intra Oral Camera System and Accessories, Model Claris I310, Sota Precision Optics, Inc. (2003) Summary page 1.

## Indications for use
Claris i310D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.

Source page: https://510kreport.com/device/K061175
Methodology: https://510kreport.com/methodology