# K042266: Acclaim

- Pathway: 510(k) (Special)
- Applicant: Air Techniques, Inc.
- Decided: Aug 31, 2004 after 8 days
- Product code: NRD (Unit, Operative Dental, Accessories)
- 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
The Acclaim system is primarily a tool to provide visual information to dental patients so they may be better equipped to make decisions about the quantity and quality of the health care they receive. This is the same intended use as previously cleared for the Vistacam Omni IC, 510(k) number 974204.

Source page: https://510kreport.com/device/K042266
Methodology: https://510kreport.com/methodology