(257 days)
ACTIVA PRESTO PACK is intended to be used by dental professionals as a dental filling material for pits, root surface cavities, and Class I, II, III, IV and V restorations include, but are not limited to, direct anterior and posterior restorations (including occlusal surfaces), core build-ups, splinting, and indirect restorations including crowns, inlays, onlays and veneers.
ACTIVA PRESTO™ PACK is an aesthetic, light cure material that contains calcium, phosphate, and fluoride in a durable, wear-resistant resin matrix indicated for all restorative procedures. The material is packable, highly polishable and contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in various shades, has low solubility, low water sorption, high physical properties, and is bioactive as demonstrated within this 510(k) submission.
The document provided is a 510(k) Premarket Notification from Pulpdent Corporation to the FDA for their device, ACTIVA PRESTO PACK. This submission focuses on demonstrating substantial equivalence to a predicate device, ACTIVA Presto (K153249), rather than presenting a study where a device's performance is measured against acceptance criteria in the format typically used for AI/ML devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to the information contained in this document, as it describes a physical dental material, not an AI/ML diagnostic or assistive device.
However, I can extract the comparative performance data between the proposed device and its predicate, which serves a similar function to "acceptance criteria" in that the new device must perform comparably to the predicate.
Here's the information extracted in a modified format to fit the request where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are implied by the performance of the legally marketed predicate device. The new device "ACTIVA™ PRESTO™ PACK" is compared against "Pulpdent ACTIVA™ PRESTO™ (K153249)". Substantial equivalence is demonstrated by comparable physical properties and intended use.
| Characteristic | Predicate Device (ACTIVA™ Presto™ K153249) | Proposed Device (ACTIVA™ PRESTO™ PACK) | Result/Comparison |
|---|---|---|---|
| Classification | Class II Dental Device, CFR 872.3690, EBF | Class II Dental Device, CFR 872.3690, EBF | Equivalent |
| Common Name | Tooth shade resin material; restorative | Tooth shade resin material; restorative | Equivalent |
| Description | Aesthetic, light cure material, urethane-based resin, flowable, stackable, contains calcium, phosphate, fluoride, no Bisphenol A, no BisGMA, no BPA derivatives | Aesthetic, light cure material, urethane-based resin, packable, sculptable, contains calcium, phosphate, fluoride, no Bisphenol A, no BisGMA, no BPA derivatives | Similar, with difference in handling characteristic (flowable vs. packable) |
| Intended Use | Light-cure, flowable composite used by dental professionals as a restorative. | Light-cure, packable composite used by dental professionals as a restorative. | Similar, with difference in handling characteristic (flowable vs. packable) |
| Indications for Use | Filling material for pits, root surface cavities, Class I, II, III, IV and V restorations. | Filling material for pits, root surface cavities, Class I, II, III, IV and V restorations. Includes direct anterior/posterior (occlusal), core build-ups, splinting, indirect restorations (crowns, inlays, onlays, veneers). | Expanded clarity in indications but functionally equivalent. |
| Contraindications | Not for direct placement on exposed pulp. | Not for direct placement on exposed pulp. | Equivalent |
| Composition | Resins: Diurethane dimethacrylate, Bis(2-(Methacryloyloxy) Ethyl) Phosphate; Fillers: Barium glass, MCP; Photoinitiator: Camphorquinone | Resins: Diurethane dimethacrylate, Bis(2-(Methacryloyloxy) Ethyl) Phosphate; Fillers: Barium glass, MCP; Photoinitiator: Camphorquinone | Equivalent |
| Technology | Light-cure polymerization, releases Ca, P, F ions. | Light-cure polymerization, releases Ca, P, F ions. | Equivalent |
| Light Cure | 20 seconds in 2 mm increments | 20 ± 2 seconds in 2 mm increments | Equivalent |
| Dispensing System | Multi-dose, push syringes (1ml, 3 ml) + applicator tips; Unit-dose capsules | Multi-dose, screw-type composite syringes; Unit-dose capsules | Similar |
| Standards | ISO 14971, ISO 10993-1, ISO 7405, ISO 4049 | ISO 14971, ISO 10993-1, ISO 7405, ISO 4049 | Equivalent |
| Appearance | Paste, various tooth shades | Paste, various tooth shades | Equivalent |
| Odor | Mild, characteristic | Mild, characteristic | Equivalent |
| Filler | 70.0% | 80.0% | Different |
| Resins | 30.0% | 20.0% | Different |
| Specific Gravity | 1.820 g/ml | 2.165 g/ml | Different |
| Depth of Cure | 2.74 mm | 2.42 mm | Similar |
| Flexural Strength | 100.1 MPa | 105.6 MPa | Higher (better) |
| Water Sorption | 36.3 µg/mm³ | 34.5 µg/mm³ | Lower (better) |
| Solubility | 4.7 µg/mm³ | 7.2 µg/mm³ | Higher (worse) |
| Radio-opacity | 2.3 mm | 2.92 mm Al | Higher (better) |
| Flexural Modulus | 5.8 GPa | 7.4 ± 0.5 GPa | Higher (better) |
| Deflection at Break | 0.70 mm | 0.54 mm | Lower (worse) |
| Compressive Strength | 327.4 MPa | 253 ± 25 MPa | Lower (worse) |
| Diametral Tensile Strength | 61 MPa | 47.6 ± 5.7 MPa | Lower (worse) |
| Polymerization Shrinkage | 2.1% | 2.1% | Equivalent |
Study Conclusion: The submission concludes that ACTIVA™ PRESTO™ PACK is substantially equivalent to ACTIVA™ Presto™ (K153249) based on comparable design, composition, performance, and intended use. While some physical properties show variation, the overall performance profile is considered acceptable for substantial equivalence for a dental restorative material. The key difference noted is the change from a "flowable" to a "packable/sculptable" composite.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a physical medical device (dental filling material), not software or an AI/ML diagnostic. The performance data presented are physical and chemical properties measured in a lab setting, not clinical data from a test set of patients.
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)
This information is not applicable. Ground truth, in the context of AI/ML, refers to definitively established diagnoses or classifications. For a dental material, "ground truth" would be established by standardized laboratory testing methods, not expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of images or data, which is not the case for material property testing.
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
This information is not applicable as the device is a dental material, not an AI/ML assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance data in this submission is derived from standardized laboratory testing protocols as per international standards like ISO 4049:2019 for Polymer-based restorative materials. These tests define how to rigorously measure properties like flexural strength, depth of cure, water sorption, etc., ensuring reproducible and objective results.
8. The sample size for the training set
This information is not applicable as the device is a physical material, not an AI/ML device that undergoes "training."
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical material, not an AI/ML device.
§ 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.