(167 days)
The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth.
· May be used as a direct restorative material
· May be used for fabrication of inlays and onlays
The Camouflage Nanohybrid Composite (Universal and Flowable) is a light cured resin-based composite restorative. It is offered in High Viscosity ("Camouflage Universal" paste) and Low Viscosity (Camouflage Flowable), and is recommended for direct and indirect placement in all caries classes (both anterior and posterior restorations, including occlusal surfaces). It is available in multiple shades and opacities, and is radioopaque. It is composed of methacrylate monomers, Initiators, inhibitors, stabilizers, pigments, and inorganic fillers coated with a coupling agent. The Camouflage Nanohybrid Composite (Universal and Flowable) cures with light in the wavelength range of 400-500nm, and a dental adhesive is used to permanently bond the restoration to the tooth structure.
The provided document is a 510(k) summary for a dental composite material, the "Camouflage NanoHybrid Composite (Universal and Flowable)." It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics. This document does NOT describe a study involving a device that requires ground truth established by experts, or human readers, or that involves AI assistance.
Therefore, I cannot provide information on:
- Sample size used for the test set and data provenance: No test set is described in the context of expert review or AI evaluation.
- Number of experts used to establish the ground truth for the test set and their qualifications: No expert ground truth establishment is described.
- Adjudication method for the test set: No adjudication method is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned.
- Standalone (algorithm only without human-in-the-loop performance) study: This type of study is not mentioned.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set: No test set ground truth is established as described.
- Sample size for the training set: There is no mention of a training set as this is not an AI or diagnostic imaging device.
- How the ground truth for the training set was established: Not applicable.
This document describes the following in relation to acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document implicitly uses ISO 4049: 2009 "Dentistry - Polymer-based restorative materials" requirements as acceptance criteria. However, explicit quantitative acceptance criteria values are not provided in the summary. Instead, the document states that the device was "evaluated using the relevant FDA recognized standard: ISO 4049: 2009" and that Prismatik "performed various testing...to provide evidence, assurance for the device safety and meeting the ISO 4049 requirements."
The document also provides a comparison table of technological characteristics between the proposed device and the predicate device. For each characteristic, it states "Same" indicating that the proposed device performs equivalently or meets the same specifications as the predicate device, which is implied to have already met relevant standards.
| Characteristic | Predicate Device (Composite 168 Restorative System) | Proposed Device (Camouflage Nanohybrid Composite) | Reported Device Performance (Similarity to Predicate) |
|---|---|---|---|
| Classification of Polymer (Per ISO 4049) | Type-1, Class-2, Group- 1&2 | Type-1, Class-2, Group- 1&2 | Same |
| Intended Uses Per FDA Regulation | Intended to restore carious lesions or structural defects in teeth | Intended to restore carious lesions or structural defects in teeth | Same |
| Indications for use per 510k Clearance Letter | • Indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth. | ||
| • May be used as a direct restorative material | |||
| • May be used for fabrication of inlays and onlays | • Indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth. | ||
| • May be used as a direct restorative material | |||
| • May be used for fabrication of inlays and onlays | Same | ||
| FDA Description and Product Code Information (EBF) | 21 CFR 872.3690 (Tooth shade resin material) | 21 CFR 872.3690 (Tooth shade resin material) | Same |
| General Material | Tooth shade resin material | Tooth shade resin material | Same |
| Delivery Method(s) | • Syringes | ||
| • Capsules Tips | • Syringes | ||
| • Capsules Tips | Same | ||
| Biocompatibility | Biocompatible | Biocompatible | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single or Multiple Use | Single Patient, multiple use | Single Patient, multiple use | Same |
| Prescription/OTC Use | Prescription | Prescription | Same |
| Specific Non-Clinical Tests (implicit acceptance based on ISO 4049 requirements met) | Results (Implicitly met ISO 4049 requirements) | ||
| Sensitivity to Ambient Light | (Not specified, assumed to meet ISO 4049) | (Not specified, assumed to meet ISO 4049) | Met ISO 4049 requirements |
| Depth of Cure | (Not specified, assumed to meet ISO 4049) | (Not specified, assumed to meet ISO 4049) | Met ISO 4049 requirements |
| Flexural Strength/Elastic Modulus | (Not specified, assumed to meet ISO 4049) | (Not specified, assumed to meet ISO 4049) | Met ISO 4049 requirements |
| Water Absorption | (Not specified, assumed to meet ISO 4049) | (Not specified, assumed to meet ISO 4049) | Met ISO 4049 requirements |
| Water Solubility | (Not specified, assumed to meet ISO 4049) | (Not specified, assumed to meet ISO 4049) | Met ISO 4049 requirements |
| Shade Match/Shade Stability | (Not specified, assumed to meet ISO 4049) | (Not specified, assumed to meet ISO 4049) | Met ISO 4049 requirements |
| Radio Opacity | (Not specified, assumed to meet ISO 4049) | (Not specified, assumed to meet ISO 4049) | Met ISO 4049 requirements |
The Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets acceptance criteria is a non-clinical testing study designed to demonstrate substantial equivalence to a predicate device.
H. Summary of Non-Clinical Testing:
- Study Design: Non-clinical (benchtop) testing.
- Testing Protocol: The Camouflage Nanohybrid Composite (Universal and Flowable) was evaluated against the relevant FDA-recognized standard: ISO 4049: 2009 Dentistry - Polymer-based restorative materials. Additionally, the study referenced the FDA's "Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions."
- Specific Tests Performed:
- Sensitivity to Ambient Light
- Depth of Cure
- Flexural Strength/Elastic Modulus
- Water Absorption
- Water Solubility
- Shade Match/Shade Stability
- Radio Opacity
I. Conclusion from the Non-Clinical Testing:
The results of these tests demonstrated that the Camouflage NanoHybrid Composite (Universal and Flowable) is substantially equivalent to the cleared predicate device, the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221. This substantial equivalence implies that the proposed device meets the same safety and effectiveness standards as the predicate device, which is presumed to have met the necessary acceptance criteria (e.g., ISO 4049).
§ 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.