(136 days)
- Prime&Bond Elect® Universal Dental Adhesive (visible light cured):
- 1.1 Direct, light cured composite and compomer restorations
- 1.2 Indirect restorations; light cured, resin cemented veneers
- 1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers
- 1.4 Composite, ceramic and amalgam repairs
- 1.5 Cavity varnish for use with fresh amalgam
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- Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure):
- 2.1 Direct, dual cure or self-cure composite restorations and core build-ups
- 2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers
- 2.3 Dual cured and self-cured resin cemented endodontic post cementation
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- Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst:
- 3.1 Adhesive bonding of direct amalgam restoration
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- Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing):
- 4.1 Indirect restorations: acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement
- 4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique
Prime&Bond Elect® Universal Dental Adhesive is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic. Prime&Bond Elect® Universal Dental Adhesive combines etchant, primer and adhesive in a one-bottle material. This robust formulation allows the operator to utilize selective phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no phosphoric acid etching prior to application, ensuring high bond strength and protection against microleakage.
When mixed with Self-Cure Activator, Prime&Bond Elect® Universal Dental Adhesive is designed to be used with DENTSPLY manufactured dual cure/self-cure resin cements* to bond all indirect restorations and DENTSPLY manufactured dual cured composite restoratives. When used with the Amalgam Bonding Accessory Kit, available separately, Prime&Bond Elect® Universal Dental Adhesive also adhesively bonds fresh amalgam to enamel and dentin.
*Note: Acid-tolerant resin cements may be used following application of Prime&Bond Elect® adhesive without the use of Self-Cure Activator, additionally allowing operator's choice of pre-cementation adhesive curing options (see complete Directions for Use).
The provided text includes information about the DENTSPLY International Inc. device, Prime&Bond Elect® Universal Dental Adhesive. However, it does not describe specific acceptance criteria in the form of numerical thresholds for device performance, nor does it detail a standalone study proving the device meets acceptance criteria.
Instead, the document states that the proposed device (Prime&Bond Elect® Universal Dental Adhesive) has an identical design and formulation to a predicate device (XENO® Adhesive with Activator, K051463), meaning the biocompatibility and performance data of the predicate device support the proposed device. A table of "Physical Properties Tested" is provided, and for each property, the result is simply "Meets specification," without providing the actual specifications or measured values.
Therefore, many of the requested items (sample size, data provenance, number of experts, adjudication method, MRMC study details, ground truth type and establishment for training, and specific acceptance criteria with numerical performance) cannot be extracted from this document, as a typical clinical study with such details was not conducted or reported for this 510(k) submission.
Here's a summary of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Film Thickness specification | Meets specification |
| Dentin Shear Bond Strength, Indirect specification | Meets specification |
| Enamel Shear Bond Strength, Indirect specification | Meets specification |
| Dentin Shear Bond Strength, Direct specification | Meets specification |
| Enamel Shear Bond Strength, Direct specification | Meets specification |
| Composite Bond Strength, Indirect specification | Meets specification |
| Base Metal Shear Bond Strength, Indirect specification | Meets specification |
| Noble Metal Shear Bond Strength, Indirect specification | Meets specification |
| Zirconia Ceramics Bond Strength, Indirect specification | Meets specification |
| Glass Ceramic Shear Bond Strength, Indirect specification | Meets specification |
| Shelf Life specification | 2 Years |
Note: The document states "all of the test results have met the specifications" but does not provide the specific numerical specifications or the measured results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document. The document relies on the predicate device's data.
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. No multi-reader, ground truth establishment study is described. The performance claim is based on equivalence to a predicate device and physical property testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
No, a MRMC comparative effectiveness study was not done. The device is a dental adhesive, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Physical property testing was done for the standalone device. The results are summarized generically as "Meets specification" without providing numerical values or sample sizes. The biocompatibility and primary performance claims are based on the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical properties listed, the "ground truth" would be established by standardized material testing procedures and their associated specifications. No details on these specific standards or how the specifications were derived are provided in this document. For the overall performance, the "ground truth" is the performance of the legally marketed predicate device (K051463), whose data was used as a basis for substantial equivalence.
8. The sample size for the training set
Not applicable. There's no machine learning algorithm described.
9. How the ground truth for the training set was established
Not applicable.
§ 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.