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K Number
K090355
Device Name
OPAL SEAL
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
2009-04-29

(77 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
K990743,K073243
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Opal® Seal is a light cure primer that is used when bonding orthodontic appliances to etched enamel.

Device Description

Bracket Adhesive Resin and Tooth Conditioner

AI/ML Overview

This is a summary of the Traditional 510(k) for Opal® Seal, a light cure primer used for bonding orthodontic appliances. The provided document does not contain a study or data to prove the device meets specific acceptance criteria. This submission focuses on establishing substantial equivalence to predicate devices based on product characteristics and intended use, not clinical performance data. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

The document indicates that the device is substantially equivalent to a predicate device (PQ1, K023042) and similar to Solo Ortho (K990743) and LED Pro Seal (K073243). The "Indications for Use" have been changed, but the specific changes and their implications for performance are not detailed.

Based on the provided information, I cannot complete the requested tables and descriptions related to acceptance criteria and performance study details. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting detailed clinical study results with acceptance criteria.

To elaborate on what is present:

  • Device Name: Opal® Seal
  • Intended Use: A light cure primer that is used when bonding orthodontic appliances to etched enamel.
  • Regulatory Classification: Class II, Product Code DYH (Bracket Adhesive Resin and Tooth Conditioner)
  • Predicate Device: PQ1 (K023042) manufactured by Ultradent Products, Inc.
  • Similar Devices (for context): Solo Ortho (K990743) and LED Pro Seal (K073243).

A 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics, materials, and intended use, rather than conducting new clinical trials with pre-defined acceptance criteria, especially for devices like this one.

§ 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.