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510(k) Data Aggregation
(94 days)
The intended use of APC™ Flash-Free Adhesive is as a light cure orthodontic adhesive that is designed to be used in bonding orthodontic appliances for orthodontic treatment.
APC™ Flash-Free Adhesive is indicated for use in bonding orthodontic appliances for orthodontic treatment.
It consists of a resin-saturated mat that is attached to the apprimated for Craceets, ceramic brackets, and bondable buccal tubes. The relatively low viscosity of the resin allows it to form a fillet at the edges of the bracket which reduces the need to remove excess adhesive, also known as flash.
The acceptance criteria and study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bond Strength Test | Provide the minimum bond strength to hold a bracket to a tooth (comparable to predicate devices) | APC™ Flash-Free Adhesive performs comparably to the predicate devices (Adhesive Precoated Brackets and APC™ Plus Adhesive) and provides the minimum bond strength to hold a bracket to a tooth. |
| Primer Compatibility Test | Provide the minimum bond strength to hold a bracket to a tooth when used with specified primers (comparable to predicate device) | APC™ Flash-Free Adhesive performs comparably to APC™ Plus Adhesive and provides the minimum bond strength to hold a bracket to a tooth when used with Transbond MIP Primer and Transbond Plus SEP Primer. |
| Accelerated Aging (Thermocycling) | Provide the minimum bond strength to hold a bracket to a tooth following specified cycles (comparable to predicate device) | APC™ Flash-Free Adhesive performs comparably to APC™ Plus Adhesive and provides the minimum bond strength to hold a bracket to a tooth following a specified number of cycles between hot and cold environments. |
| Ambient Light Stability Test | Provide the minimum bond strength to hold a bracket to a tooth following ambient light exposure (comparable to predicate device) | APC™ Flash-Free Adhesive performs comparably to APC™ Plus Adhesive and provides the minimum bond strength to hold a bracket to a tooth following exposure to ambient light. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each nonclinical performance test (bond strength, primer compatibility, accelerated aging, ambient light stability). However, these are bench tests, a common practice in dental material testing. The data provenance is from nonclinical, bench-top testing conducted by 3M Unitek Corporation. The country of origin for the data is not specified but implicitly assumed to be the United States, where the company is based and seeking FDA clearance. The data is prospective for the device being tested, in the sense that the tests were performed specifically to evaluate the performance of APC™ Flash-Free Adhesive.
3. Number of Experts and Qualifications for Ground Truth
No human experts were used to establish ground truth for the test set. All testing described is nonclinical bench testing to evaluate physical properties of the adhesive.
4. Adjudication Method for the Test Set
No adjudication method was used as the testing involved objective physical measurements (e.g., bond strength) rather than subjective human assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as this is a physical dental adhesive, not an imaging or diagnostic device requiring human interpretation of cases.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done, as this device is a physical product (an adhesive), not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for these nonclinical tests was based on objective physical measurements (e.g., bond strength values) and comparison against the performance of legally marketed predicate devices, which are accepted as safe and effective.
8. Sample Size for the Training Set
This device is a physical product (adhesive), not an AI/ML algorithm requiring a training set. Therefore, there is no training set sample size.
9. How Ground Truth for Training Set Was Established
As there is no training set for a physical adhesive, this question is not applicable.
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(93 days)
- All classes of fillings (according to Black) with lightcuring composite or compomer
- Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX™ ARC, manufactured by 3M ESPE
- Core build-ups made of light-curing composite
- Root surface desensitization
- Repair of composite or compomer fillings
- Repair of restorations veneered with composite or ceramic
- Bonding orthodontic appliances to teeth for orthodontic treatment
Uno is classified Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Uno offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itself, Uno is well suited for bonding methacrylate based composites to dentin and enamel. Uno is also indicated to seal sensitive root surfaces as is Adper Prompt L-Pop. Furthermore, Uno is suited to bond orthodontic appliances to teeth for orthodontic treatment as is Prompt L-Pop. Like Adper Prompt L-Pop, Uno will be available in single dose applicators and in a vial version.
This document pertains to a 510(k) summary for a dental adhesive product called "Uno" and does not contain information about the acceptance criteria or a study proving its performance against such criteria in the context of an AI/ML device.
The provided text describes a "Resin Tooth Bonding Agent" and its substantial equivalence to predicate devices, focusing on its chemical composition, intended use (bonding restorative materials, sealing root surfaces, bonding orthodontic appliances), and biocompatibility.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance: This document is for a physical dental adhesive, not an AI/ML device.
- Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, or ground truth establishment for a test set: These concepts are relevant to the evaluation of AI/ML devices, not a resin tooth bonding agent.
The document states, "To provide evidence for safety biocompatibility testing was carried out. The results show that Uno is a safe device." This is the extent of any "study" mentioned, and it only addresses biocompatibility for safety, not performance against specific clinical efficacy metrics. The primary mechanism for clearance is demonstrating "substantial equivalence" to existing, legally marketed predicate devices.
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