(162 days)
TKO is a pink, flowable light cure composite gel for the creation of occlusal buildups (bite turbos) and as a retainer repar composite.
Intended for use in the creation of occlusal buildups (bite turbos) and as a retainer repair composite. It bonds to enamel, porcelain, acrylic and metal for duration of treatment externally communicating device that contacts tissue/bone/dentin.
TKO Composite Bite Turbo Gel is dispensed from a precision 3.5 gm LuerLoc syringe with tips.
The provided document is a 510(k) Premarket Notification from the FDA for a dental product called "TKO Composite Bite Turbo Gel." It outlines the device's characteristics, intended use, and a comparison with legally marketed predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: This document pertains to a medical device (dental resin) and not an AI/ML enabled device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., MRMC studies, training set details, expert ground truth adjudication) are not applicable and thus not present in the document. The study described focuses on non-clinical, physical, and chemical performance testing to demonstrate substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Test Method | Unit | Acceptance Criteria (Requirement) | Reported Device Performance (Test Result) |
|---|---|---|---|---|
| Shear Bond Strength (Enamel) | RD-022 | MPa | 5 sample average ≥ 8 | Pass (16.47 ± 4.24) |
| Shear Bond Strength (Steel) | RD-022 | MPa | 5 sample average ≥ 8 | Pass (36.157 ± 1.37) |
| Shear Bond Strength (Porcelain) | RD-022 | MPa | 5 sample average ≥ 8 | Pass (21.54 ± 5.12) |
| Shear Bond Strength (Acrylic) | RD-022 | MPa | 5 sample average ≥ 8 | Pass (24.28 ± 3.57) |
| Flexural Strength | ISO-4049:2019 | MPa | 4 of 5 samples ≥ 80 | Pass (5 of 5 samples > 80) |
| Hardness after Cure | QC-006 | N/mm² | > 69 Top, > 67 Bottom (After 20 s L/C) | Pass (>69 Top, > 67 Bottom) |
| Depth of Cure | ISO 4049:2019 | mm | 3 of 3 samples ≥ 1.5 | Pass (3 of 3 samples > 1.5) |
| Sensitivity to Ambient Light | ISO 4049:2019 | Homogeneous visual inspection | 3 of 3 samples (homogenous) | Pass (3 of 3 samples homogenous) |
| Water Sorption | ISO 4049:2019 | µg/mm³ | 4 of 5 |
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.