# K052477: Damon 3 Modified

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Nov 30, 2005 after 82 days
- Product code: DYW (Bracket, Plastic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Damon 3: named in the summary without a submission number

## Most influential descendants
- K051953: Everstick a&O (2006), 0 descendants of its own

## Recalls of this device
- Nov 3, 2005 · Not classified · Z-0203-06: Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
- Nov 3, 2005 · Not classified · Z-0204-06: Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.

## Indications for use
Damon 3 Modified is a polycarbonate bracket system intended to aid in the movement of patient's teeth during orthodontic treatment.

Source page: https://510kreport.com/device/K052477
Methodology: https://510kreport.com/methodology