# K072978: Tender Ortho Bond-Ena Bond-Ena Etch

- Pathway: 510(k) (Traditional)
- Applicant: Micerium S.P.A.
- Decided: Jan 17, 2008 after 87 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) Transbond Plus SE: named in the summary without a submission number

## Indications for use
Adhesive for luting ceramic and metal orthodontic brackets

Source page: https://510kreport.com/device/K072978
Methodology: https://510kreport.com/methodology