(42 days)
PULPDENT DENTASTIC UNO-DUO is a kit containing DenTASTIC UNO, a singlecomponent light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNO-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which a dual cure product is indicated.
PULPDENT UNO-DUO is a kit containing DenTASTIC UNO, a single-component light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNC-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which helshe prefers a self-cure or dual cure product.
The provided document is a 510(k) premarket notification for a dental bonding agent, PULPDENT UNO-DUO. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study with detailed statistical analysis.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, MRMC study, ground truth details) cannot be fully populated from this document. The document's primary "study" is a comparison to legally marketed predicate devices and reliance on existing research.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or detailed performance metrics in a tabular format. The "acceptance criteria" for a 510(k) submission are typically met by demonstrating substantial equivalence to predicate devices. The performance is assessed by claiming it is substantially equivalent in composition, intended use, safety, and effectiveness.
| Acceptance Criteria Category | Reported Device Performance (based on substantial equivalence) |
|---|---|
| Composition | Substantially equivalent to listed predicate devices (PULPDENT UNO, PULPDENT DENTASTIC, Dentsply / Caulk PRIME & BOND NT DUAL CURE). Uses same technology as ADA Health Foundation's DenTASTIC and DenTASTIC UNO. |
| Intended Use | Substantially equivalent to predicate product. Used by dentists to bond to dentin, enamel, metals, and resins where a self-cure or dual cure product is preferred. |
| Safety | Components have been used in legally marketed predicate dental devices. General usage of these materials over 20 years indicates a high benefit-to-risk ratio, are relatively trouble-free, with no evidence of short-term or long-term risk and no suspicion of problems after billions of procedures. |
| Effectiveness | Supported by research from ADA Health Foundation, research papers, and evaluation by editors of Reality, 1999. Predicate product obtained 510(k) Premarket approval as Class II Dental Devices under CFR 872.3690. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it relies on substantial equivalence and existing data, not a new comparative study with a "test set" in the traditional sense.
- Data Provenance: The document refers to "research performed at the ADA Health Foundation," "research papers," and "evaluation by the editors of Reality, 1999." It also mentions "General usage of these materials over about 20 years" and "billions of procedures in the United States," implying broad historical clinical experience. This suggests a retrospective review of existing literature and clinical history, rather than a specific prospective study for this device. The country of origin for the ADA Health Foundation research would be the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for this submission is based on the established safety and effectiveness of the predicate devices and the underlying technology, validated through existing research and regulatory approvals, rather than a new expert-adjudicated test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set or expert adjudication process is described in this 510(k) summary.
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 a dental bonding agent, not an AI-assisted diagnostic device, so an MRMC study comparing human readers with/without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (dental bonding agent), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the claims of safety and effectiveness is largely based on:
- Existing regulatory approvals: Predicate devices have 510(k) Premarket approval.
- Scientific research/literature: "Research performed at the ADA Health Foundation" and "research papers."
- Historical clinical outcomes data/experience: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio... There is no suspicion of any problems after virtually billions of procedures in the United States."
8. The sample size for the training set
Not applicable. This is a medical device being evaluated for substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device being evaluated for substantial equivalence, not a machine learning model.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.