# K012744: Intraoral Lens Option to Spectroshade

- Pathway: 510(k) (Traditional)
- Applicant: Mht Optic Research AG
- Decided: Jan 23, 2002 after 160 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SpectroShade's intraoral lens option is an accessory imaging device, which is intended for use by dental professionals in taking intraoral images of dental anatomy in order to: 1) Assist in the assessment of the overall patient's dental health by providing magnified digital images of the oral cavity. 2) Provide visual educational information to the patient to more effectively communicate a treatment plan. 3) Provide documented images for patient records, insurance companies, and other dental professionals. 4) Allow the practitioner to display before and after images of dental procedures.

Source page: https://510kreport.com/device/K012744
Methodology: https://510kreport.com/methodology