# K002620: Suresmile System

- Pathway: 510(k) (Traditional)
- Applicant: Orametrix, Inc.
- Decided: Nov 16, 2000 after 85 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 K941452 (1994). 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)
- K984332: Spectra VU 1000 Series Intraoral Camera, Spectra VU 2000 Series Intraoral Camera, Spectra VU Hddi SV I Intraoral Camera,, International Technology Concepts (1999) Summary page 1.

## Indications for use
The SureSmile™ System is used to provide a total orthodontic care solution to orthodontists with an image acquisition and viewing technology that delivers value throughout the entire care cycle; including record collection, treatment planning, treatment delivery, monitoring of care and patient communication. This treatment objective is then used to design a custom appliance system, prescribed by the orthodontist, which is specific to each patient’s needs. The result is a comprehensive care solution that addresses many problems that orthodontists face with patient care. The OraScanner is not intended for use as an operative device and is not manufactured to be sterile.

Source page: https://510kreport.com/device/K002620
Methodology: https://510kreport.com/methodology