# K061042: Linglock

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties
- Decided: Jan 19, 2007 after 280 days
- Product code: DYW (Bracket, Plastic, 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.
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. The FDA summary names its predicate without a number.
- (no number) Ormco Corporation, Bondable Lingual Retainer: named in the summary without a submission number
- (no number) 3M Unitek, Clarity Ceramic Brackets: named in the summary without a submission number

## Indications for use
LingLock is an interlock retainer composed of polycrystalline alumina that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.

Source page: https://510kreport.com/device/K061042
Methodology: https://510kreport.com/methodology