PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

• K Number: K012673
• Device Name: PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
• Manufacturer: PRIME DENTAL MANUFACTURING, INC.
• Date Cleared: 2001-10-24 ( 71 days)
• Product Code: DYH
• Regulation Number: 872.3750
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Prime-Dent® One-Step Orthodontic Adhesive Bonding System is a resin/paste system intended for bonding plastic, metal or ceramic orthodontic brackets to etched enamel. An active archwire may be placed immediately after adhesive has properly cured.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental adhesive bonding system, which primarily confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance. It does not contain details of a clinical study or performance data that would answer your questions.

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.