# K012673: Prime-Dent One-Step Orthodontic Adhesive Bonding System

- Pathway: 510(k) (Traditional)
- Applicant: Prime Dental Manufacturing, Inc.
- Decided: Oct 24, 2001 after 71 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Prime-Dent® One-Step Orthodontic Adhesive Bonding System is a resin/paste orthodontic bracket bonding system for use with any type of bracket bonded to any enamel, porcelain, composite or metal surface when properly conditioned. An active archwire may be placed immediately after adhesive has properly cured.

Source page: https://510kreport.com/device/K012673
Methodology: https://510kreport.com/methodology