# K990743: Solo Ortho

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Jun 4, 1999 after 88 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- 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, Solo Plus Ortho: named in the summary without a submission number

## Indications for use
Solo Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

Source page: https://510kreport.com/device/K990743
Methodology: https://510kreport.com/methodology