# K250015: Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corporation
- Decided: Jan 3, 2025 after 1 day
- 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
Longest line of descent: 7 generations back to K900510 (1990). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941015: Ormco System 1+ (TM), Ormco Corp. (1994) Summary page 4.
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 4.
- K880393: Transbond Light Cured Orthodontic Adhesive, Unitek Corp. (1988) Summary page 4.

## Indications for use
Ormco™ EtchFree Bonding Primer is a bonding primer intended to bond orthodontic appliances such as metal brackets, ceramic brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco’s Ortho Solo™ and an adhesive/cement without etching. Ormco™ EtchFree Adhesive is a light-curing orthodontic bonding adhesive that is intended to be used for the attachment of orthodontic appliances to teeth such as metal bracket, ceramic brackets, and aligner attachments.

Source page: https://510kreport.com/device/K250015
Methodology: https://510kreport.com/methodology