# K081415: Damon 4CLEAR

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Sep 24, 2008 after 127 days
- Product code: NJM (Bracket, Ceramic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices 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) Lumina: named in the summary without a submission number
- (no number) In-Ovation C: named in the summary without a submission number
- (no number) Clarity Modified Ceramic Bracket: named in the summary without a submission number

## Most influential descendants
- K173440: Carriere SLX 3D Clear (2018), 1 descendant of its own
- K111234: Click-IT (2011), 1 descendant of its own
- K230225: DynaFlex Clear Brackets & Buttons (2023), 0 descendants of its own
- K192202: Clear21 (2019), 0 descendants of its own
- K172845: Symetri Clear (2018), 0 descendants of its own

## Indications for use
The Damon 4Clear is a ceramic bracket system intended to aid in the movement of patient teeth during orthodontic treatment.

Source page: https://510kreport.com/device/K081415
Methodology: https://510kreport.com/methodology