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K Number
K033703
Device Name
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
Manufacturer
DENTSPLY INTL.
Date Cleared
2004-02-06

(73 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
K933766
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bonding of orthodontic brackets to natural and artificial tooth surfaces

Device Description

The IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE system is a two-part light-cure system: an adhesive and a primer. A tooth conditioner is available if desired for the highest stress bonding cases. IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE bonds metal, plastic, and ceraine orthodontic brackets to natural teeth, acrylic teeth, porcelain crowns, or amalgams. The adhesive is packaged in syringes. No mixing is necessary. The primer is packaged in unit dose, self-dispensing capsules.

AI/ML Overview

The provided 510(k) summary for K033703 describes an orthodontic bracket adhesive. However, it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The submission focuses on establishing substantial equivalence to a predicate device (High-Q-Bond Adhesive Resin Cement K933766) based on:

  1. Technological Characteristics: Stating that "All of the components found in the IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE have been used in legally marketed devices or were found safe for dental use."
  2. Claim of Prior Use and Performance Data: "We believe that the prior use of the components of the IDEAL® I ORTHODONTIC BRACKET ADHESIVE in legally marketed devices, the performance data provided, and the similarity of the predicate to the new device support the safety and effectiveness..."

Therefore, I cannot fulfill your request as there is no mention of acceptance criteria or a specific study proving device performance against those criteria in the provided text.

To address your request, such information would typically be found in a detailed "Performance Data" or "Non-Clinical Studies" section within a 510(k) submission, which is absent here.

§ 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.