(60 days)
Glidewell TuffSplint™ Appliance Resin is indication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
Glidewell TuffSplint™ Appliance Resin is a light-cured resin for the fabrication of orthodontic and dental appliances. The resin can be used in DLP printers utilizing a wavelength of 385nm. The final medical device is a custom fitted appliance that is compliant to the dental professional's diagnosis and prescription. Glidewell TuffSplint™ Appliance Resin, in its final fabricated form, is a removable appliance that is fitted to a patient's oral anatomy and is maintained by the patient. The mechanism of a patient fitting starts with creating an impression of the patient's teeth via traditional or digital techniques, and then transferring that impression into a finished appliance via a validated 3D printing workflow.
This document is an FDA 510(k) Premarket Notification for a dental resin, Glidewell TuffSplint™ Appliance Resin. It details the device's characteristics and compares them to a predicate device, KeyPrint KeySplint Soft Resin (K183598), to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard) | Device Performance (Glidewell TuffSplint™) |
|---|---|---|
| Flexural Strength | ISO 20795-2:2013 | Met the acceptance criteria. |
| Flexural Modulus | ISO 20795-2:2013 | Met the acceptance criteria. |
| Water Sorption | ISO 20795-2:2013 | Met the acceptance criteria. |
| Water Solubility | ISO 20795-2:2013 | Met the acceptance criteria. |
| Tensile Strength | ASTM D638-14 | Met the acceptance criteria. |
| Tensile Modulus | ASTM D638-14 | Met the acceptance criteria. |
| Elongation | ASTM D638-14 | Met the acceptance criteria. |
| Printing Accuracy | Pre-specified tolerance for design input dimensions | Met the pre-specified acceptance criteria. |
| Printing Orientation | Same performance criteria regardless of print direction/location | Met the pre-specified acceptance criteria and demonstrated reliable fabrication. |
| Packaging Validation | ASTM D4169-16 (manual handling, compressive loads, repetitive shocks, low pressure, vibration, impacts, drops) and ullage test (heated environment at 55°C) | Suitable for use. |
| Biocompatibility | ISO 10993-1:2018 | No biocompatibility concern. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of specimens for flexural strength, water sorption, etc.). It only states that "All the testing results met the acceptance criteria."
The data provenance is from non-clinical bench testing performed by Prismatik Dentalcraft, Inc. The document does not specify the country of origin of the data beyond the company's location in Irvine, CA, USA. The studies are by nature prospective as they were conducted specifically for this submission to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a submission for a material (resin) which undergoes physical and chemical property testing, not an AI/software device that requires expert-reviewed ground truth for performance evaluation against a gold standard. The "ground truth" here is objective physical and chemical measurements against established international standards (ISO, ASTM).
4. Adjudication Method for the Test Set
Not applicable. See point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device. The "standalone" performance here refers to the material's properties as measured in a lab setting, which is what was done.
7. The Type of Ground Truth Used
The ground truth used for these tests were established international standards and methodologies (ISO 20795-2:2013, ASTM D638-14, ISO 10993-1:2018, ASTM D4169-16). These standards define the test procedures and the performance thresholds for the respective properties.
8. The Sample Size for the Training Set
Not applicable. This is a physical material, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
N/A