(111 days)
This Device is intended for use as a light cure, orthodontic adhesive.
This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.
The provided text describes a 510(k) submission for the "Quantum LB" orthodontic adhesive. The study aims to demonstrate substantial equivalence to a predicate device, Transbond XT.
Here's an analysis of the acceptance criteria and the study presented:
Quantum LB Orthodontic Adhesive - Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the Quantum LB device, as per the provided summary, is similar performance to the predicate device (Transbond XT) in shear bond strength. No specific numerical thresholds are given for this similarity, but the summary states it was achieved.
| Property | Acceptance Criteria (Implied) | Reported Device Performance (Quantum LB) |
|---|---|---|
| In-vivo Shear Bond Strength | Similar to Transbond XT | "Testing resulted in similar performance between the two adhesives." |
| Biocompatibility (Local/Systemic Effects) | No adverse effects | "determined to not directly or through the release of material constituents produce adverse local or systemic effects." |
| Cytotoxicity (ISO 10993-5 Elution Method) | Grade |
§ 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.