(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2016
Dentsply Sirona Helen Lewis Director Corporate Regulatory Affairs 221 W Philadelphia St, Suite 60 York, Pennsylvania 17404
Re: K162107
Trade/Device Name: Tph Spectra+ Universal Composite Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: July 28, 2016 Received: July 29, 2016
Dear Helen Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
TPH Spectra® + Universal Composite Restorative
Indications for Use (Describe)
TPH Spectra® + Universal Composite Restorative is 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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
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510(k) SUMMARY for TPH Spectra® + Universal Composite Restorative
Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: July 28, 2016
Device Name:
- Proprietary Name: ●
- . Classification Name:
- CFR Number: .
- Device Class: .
- Product Code: ●
Predicate Device:
TPH Spectra® + Universal Composite Restorative Tooth Shade Resin Material 872.3690 II EBF
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Filtek™ Supreme Ultra Universal Restorative | K083610 | 3M ESPE |
Description of Device:
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.
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Indications for Use:
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
Substantial Equivalence:
Technological Characteristics:
Information provided in this 510(k) submission shows that TPH Spectra® + Universal Composite Restorative supports substantial equivalence when compared to the predicate device, Filtek "" Supreme Ultra Universal Restorative (K083610) in terms of intended use, indications for use, composition, physical properties and technological characteristics.
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| Element | Predicate DeviceFiltek™ Supreme Ultra Universal Restorative | Proposed DeviceTPH Spectra® + Universal CompositeRestorative | Difference |
|---|---|---|---|
| 510(k) | K083610 | To be assigned | |
| Indicationsfor use | Direct anterior and posterior restorations• (including occlusal surfaces)• Core build-ups• Splinting• Indirect restorations including inlays,onlays and veneers | Direct or indirect replacement of missingor deficient tooth structure in primary andpermanent anterior and posterior teeth,e.g.1. Direct anterior and posteriorrestorations (including occlusalsurfaces)2. Core build-ups3. Splinting4. Indirect restorations including inlays,onlays and veneers | "Direct or indirect replacement ofmissing or deficient tooth structurein primary and permanent anteriorand posterior teeth" is a descriptionof the indications in general.Indications of the proposed deviceare the same as the predicate device.According to ISO 4049, the physicalproperty data support that theproposed device meets therequirements primarily for the directand indirect restorations. |
| Compositionof Materials | Methacrylate-based resin, photo initiator,fillers and pigments. | Methacrylate-based resin, photo initiator,fillers and pigments. | Chemically similar to the predicatedevice. |
| PhysicalProperties | Radiopacity: 2.10 (0.0) mmAlFracture Toughness: $1.64 (0.09) MPa.m^{1/2}$Fluorescence: similar to a natural tooth.Depth of Cure: 2.60 (0.02) mmFlexural Strength: 131 (14) MPaFlexural Modulus: 10.6 (0.6) MPaWater Sorption: 33.1 (2.1) µg/mm³Water Solubility: 1.0 (0.7) µg/mm³Localized Wear Loss: 0.87 (0.24) x10⁻² mm³Sensitivity to Ambient Light: 135 sShade and Color Stability: Stable/PassStain Resistance: 3.30 (1.06) | Radiopacity: 2.23 (0.08) mmAlFracture Toughness: $1.71 (0.16) MPa.m^{1/2}$Fluorescence: similar to a natural tooth.Depth of Cure: 2.12 (0.02) mmFlexural Strength: 117 (10) MPaFlexural Modulus: 11.6 (0.8) MPaWater Sorption: 19.3 (1.9) µg/mm³Water Solubility: 0 µg/mm³Localized Wear Loss: 0.47 (0.15) x10⁻² mm³Sensitivity to Ambient Light: 180 sShade and Color Stability: Stable/PassStain Resistance: 1.69 (0.25) | Physical property data supportsubstantial equivalence of theproposed device when compared tothe predicate device. |
Table 5.1 Similarities and Differences between the proposed and the predicate devices
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Biocompatibility Testing:
An evaluation of biocompatibility was performed for the TPH Spectra® + Universal Composite Restorative in accordance with ISO 10993-1(Biological Evaluation of Medical Devices- Part1: Evaluation and Testing) and ISO 7405 (Dentistry - Evaluation of Biocompatibility of Medical Devices used in Dentistry). TPH Spectra® + Universal Composite Restorative has been demonstrated as biocompatible for its intended use.
Physical Properties:
In-vitro bench tests were performed on the TPH Spectra® + Universal Composite Restorative including Radiopacity, Fracture Toughness, Fluorescence, Depth of Cure, Flexural Strength, Flexural Modulus, Water Sorption and Solubility, Localized Wear Loss, and Sensitivity to Ambient Light. The compressive strength was no evaluated due to the unbonded, free standing failure mode of the test which is clinically irrelevant under real clinical situations. The results indicated that the TPH Spectra® + Universal Composite Restorative meets or exceeds the requirements of ISO 4049: 2009 (Dentistry -- Polymer-based restorative ) or DENTSPLY internal standards and supports substantial equivalence when compared to the predicate devices on physical properties.
Clinical Performance Data:
No clinical performance data was submitted.
Risk Analysis
The risk analysis of TPH Spectra® + Universal Composite Restorative was conducted by a design Failure Mode and Effects Analysis (FMEA).
As designed, the residual risk of the TPH Spectra® + Universal Composite Restorative is considered acceptable. The benefits of the product are considered to outweigh the risks outlined in the risk analysis.
Conclusion Regarding Substantial Equivalence:
TPH Spectra® + Universal Composite Restorative is a composite which is intended to be used for anterior and posterior restorations and cosmetic and functional reshaping of primary and permanent teeth. The TPH Spectra® + Universal Composite Restorative has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate Filtek™ Supreme Ultra Universal Restorative cleared under premarket notification K083610. Test data to verify the performance of the TPH Spectra® + Universal Composite Restorative has been provided for Radiopacity, Fracture Toughness, Fluorescence, Depth of Cure, Flexural Strength, Flexural Modulus, Water Sorption and Solubility, Localized Wear Loss, and Sensitivity to Ambient Light.
Combined with the design and intended use comparison with the predicate device, we have determined that the proposed device TPH Spectra® + Universal Composite Restorative supports substantial equivalence when compared to predicate device Filtek™ Supreme Ultra Universal Restorative (K083610).
§ 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.