FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This 510(k) summary focuses on the PMN number K992518 which is for a new intended use of an existing device, Prime & Bond® NT™ Dental Adhesive System (predicate K982394). The new intended use is for "pit and fissure sealant".

The acceptance criteria for this new indication appear to be related to achieving comparable adhesive strength to enamel as existing methods when used with pit and fissure sealants.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Short-term Adhesion: Adhesive strength to enamel (24h) when used with Dyract® Seal Compomer Pit & Fissure Sealant is comparable to Dyract® Seal with an acid etchant pretreatment.	Immediate Adhesion (24h):

Nupro® Prophylaxis + NRC™ Conditioner + Prime & Bond® NT™ Adhesive + DyractSeal™: $11.09 \pm 2.38$ MPa
Nupro® Prophylaxis + Etchgel Conditioner + Prime & Bond® NT™ Adhesive + DyractSeal™: $13.01 \pm 3.21$ MPa
Nupro® Prophylaxis + Etchgel Conditioner + DyractSeal™: $12.93 \pm 1.41$ MPa
The performance with Prime & Bond® NT™ Adhesive pretreated with NRC™ Conditioner ($11.09 \pm 2.38$ MPa) is numerically lower than the acid etchant alone ($12.93 \pm 1.41$ MPa) at 24 hours, but the inclusion of Prime & Bond® NT™ with acid etchant ($13.01 \pm 3.21$ MPa) shows comparable or slightly better strength than acid etchant alone. The text states "develops an adhesive strength to enamel that is comparable to Dyract® Seal Compomer Pit & Fissure Sealant with an acid etchant pretreatment." which suggests the $11.09 \pm 2.38$ MPa is considered comparable. |
| Long-term Adhesion: Durable adhesion resulting in long-term protection against microleakage, as demonstrated by adhesion over months. Specifically, adhesion using NRC™ Non-Rinse Conditioner and Prime & Bond® NT™ Dental Adhesive should be comparable to DeTrey® Conditioner 36 (36% phosphoric acid gel). | Long-term Adhesion (up to 12 months):

NRC™ Non-Rinse Conditioner and Prime & Bond® NT™ Dental Adhesive:

0 months: $12.5 \pm 2.1$ MPa
2 months: $9.4 \pm 2.0$ MPa
4 months: $11.7 \pm 0.6$ MPa
6 months: $11.2 \pm 2.6$ MPa
8 months: $10.5 \pm 1.7$ MPa
12 months: $9.4 \pm 2.2$ MPa

DeTrey® Conditioner 36 (36% phosphoric acid gel):

0 months: $14.1 \pm 1.8$ MPa
2 months: $12.0 \pm 0.64$ MPa
4 months: $11.7 \pm 1.0$ MPa
6 months: $11.1 \pm 1.8$ MPa
8 months: $12.5 \pm 1.8$ MPa
12 months: $10.5 \pm 2.2$ MPa
The results show similar trends and magnitudes, particularly at later time points (4, 6, 8, 12 months), supporting comparability. |
| Micromorphology: Good bonding properties observed at a microscopic level. | Micromorphology study: "the results showed good bonding properties." (Details are in Exhibit A, which is not provided). |

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for either the 24-hour or long-term adhesion tests. The adhesion values are presented with standard deviations, implying multiple measurements were taken, but the 'n' value (number of samples/teeth) is missing.
Data Provenance: The document does not specify the country of origin. It is a submission to the FDA, suggesting the studies were conducted by or for DENTSPLY International. The studies appear to be prospective experimental studies (in-vitro adhesion tests) conducted specifically for this submission, although the document does not explicitly state "prospective."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This study involves material science testing (adhesion strength, micromorphology) rather than clinical diagnosis or interpretation by experts. The "ground truth" here is the measured physical properties of the materials.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions or diagnostic findings.

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 a study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth relies on physical measurement data (adhesion strength, micromorphological observations) generated from laboratory experiments. In this context, the "ground truth" is the established scientific methods and resulting data for evaluating dental material properties.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device that requires a training set.

Summary

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.