# K072643: Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/US

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corporation
- Decided: Nov 16, 2007 after 59 days
- Product code: KZN (Scanner, Color)
- Device class: 2
- Regulation: 21 CFR 872.3661
- 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) VITAPAN CLASSICAL Shade Guide: named in the summary without a submission number
- (no number) VITA SYSTEM 3D-MASTER Tooth Guide: named in the summary without a submission number
- (no number) Ivoclar Vivadent Chromascop: named in the summary without a submission number
- (no number) NORITAKE Shade Guide: named in the summary without a submission number
- (no number) Vintage Halo NCC: named in the summary without a submission number

## Indications for use
The Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US is intended for use in automated color shade-matching to assist in dental restoration. The targeted teeth for color analysis are the left and right central incisors, lateral incisors and canines.

Source page: https://510kreport.com/device/K072643
Methodology: https://510kreport.com/methodology