(60 days)
TPH Spectra® + Universal Composite Restorative is indicated for direct or indirect replacement of missing or deficient tooth structure in primary and permanent anterior and posterior teeth, e.g.,
- Direct anterior and posterior restorations (including occlusal surfaces)
- Core build-ups
- Splinting
- Indirect restorations including inlays, onlays
TPH Spectra® + Universal Composite Restorative is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and permanent teeth. The new device contains methacrylate-based resin, photo initiator, silanated inorganic filler and pigments. Available shades include opaque dentin shades, regular body shades and translucent enamel shades. This restorative provides high strength and low wear for durability.
TPH Spectra® + Universal Composite Restorative is applied to the tooth following use of a methacrylate-based dental adhesive and/or a cement, such as manufactured by DENSTPLY, which permanently bonds the restoration to the tooth structure.
TPH Spectra® + Universal Composite Restorative is packaged in traditional multi-use syringes, for outside-the-mouth dispensing onto a mixing pad, and in pre-dosed Compules® Tips for intraoral dispensing. The restorative composite in Compules® Tips is dispensed using a DENTSPLY Compules® Tips Gun.
The document is a 510(k) Premarket Notification for the TPH Spectra+ Universal Composite Restorative. It aims to demonstrate substantial equivalence to a predicate device, the Filtek™ Supreme Ultra Universal Restorative (K083610).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the physical properties of the predicate device and the relevant ISO standards (ISO 4049: 2009 for Polymer-based restorative materials, and DENTSPLY internal standards). The reported device performance is presented in "Table 5.1 Similarities and Differences between the proposed and the predicate devices" on page 5.
| Element | Acceptance Criteria (Predicate Device Performance / ISO 4049:2009 Requirements) | Reported Device Performance (TPH Spectra® + Universal Composite Restorative) | Difference/Comment (from document) |
|---|---|---|---|
| Radiopacity | 2.10 (0.0) mmAl (Predicate) | 2.23 (0.08) mmAl | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. |
| Fracture Toughness | $1.64 (0.09) MPa.m^{1/2}$ (Predicate) | $1.71 (0.16) MPa.m^{1/2}$ | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. |
| Fluorescence | Similar to a natural tooth (Predicate) | Similar to a natural tooth | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. |
| Depth of Cure | 2.60 (0.02) mm (Predicate) | 2.12 (0.02) mm | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. The document also states the device "meets or exceeds the requirements of ISO 4049: 2009 (Dentistry -- Polymer-based restorative ) or DENTSPLY internal standards" (page 6). |
| Flexural Strength | 131 (14) MPa (Predicate) | 117 (10) MPa | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. The document also states the device "meets or exceeds the requirements of ISO 4049: 2009 (Dentistry -- Polymer-based restorative ) or DENTSPLY internal standards" (page 6). |
| Flexural Modulus | 10.6 (0.6) MPa (Predicate) | 11.6 (0.8) MPa | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. |
| Water Sorption | 33.1 (2.1) µg/mm³ (Predicate) | 19.3 (1.9) µg/mm³ | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. The document also states the device "meets or exceeds the requirements of ISO 4049: 2009 (Dentistry -- Polymer-based restorative ) or DENTSPLY internal standards" (page 6). |
| Water Solubility | 1.0 (0.7) µg/mm³ (Predicate) | 0 µg/mm³ | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. The document also states the device "meets or exceeds the requirements of ISO 4049: 2009 (Dentistry -- Polymer-based restorative ) or DENTSPLY internal standards" (page 6). |
| Localized Wear Loss | 0.87 (0.24) x10⁻² mm³ (Predicate) | 0.47 (0.15) x10⁻² mm³ | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. |
| Sensitivity to Ambient Light | 135 s (Predicate) | 180 s | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. The document also states the device "meets or exceeds the requirements of ISO 4049: 2009 (Dentistry -- Polymer-based restorative ) or DENTSPLY internal standards" (page 6). |
| Shade and Color Stability | Stable/Pass (Predicate) | Stable/Pass | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. |
| Stain Resistance | 3.30 (1.06) (Predicate) | 1.69 (0.25) | Physical property data support substantial equivalence of the proposed device when compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the in-vitro bench tests for each physical property. It only provides the mean and standard deviation for the measurements. The provenance of the data is from Dentsply Sirona's internal testing as part of their 510(k) submission. No information is given about the country of origin of the data or whether the test studies were retrospective or prospective beyond being in-vitro bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This submission relies on in-vitro bench testing against a predicate device and ISO standards, not on expert consensus for a test set.
4. Adjudication Method for the Test Set
Not applicable. Ground truth for in-vitro physical property tests is established by physical measurement methods, not expert adjudication.
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 an AI/CAD device. It is a dental restorative material undergoing a 510(k) submission based on substantial equivalence to a predicate device through physical property comparisons and biocompatibility testing. No clinical performance data was submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CAD algorithm.
7. The type of ground truth used
The ground truth for the physical properties is established through:
- Comparison to the physical properties of the legally marketed predicate device (Filtek™ Supreme Ultra Universal Restorative).
- Compliance with international standards, specifically ISO 4049: 2009 (Dentistry -- Polymer-based restorative materials).
- Compliance with DENTSPLY internal standards.
The ground truth for biocompatibility is established through testing in accordance with ISO 10993-1 and ISO 7405.
8. The sample size for the training set
Not applicable. This device is a material, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this 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.