(60 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental composite material, with no mention of AI or ML.
No
The device is a restorative material used for repairing or replacing tooth structure, which is a structural rather than a therapeutic function.
No
Explanation: The device is a restorative material used for repairing teeth, not for diagnosing conditions.
No
The device description clearly states it is a visible light cured, radiopaque, composite restorative material composed of methacrylate-based resin, photo initiator, silanated inorganic filler, and pigments, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for direct or indirect replacement of missing or deficient tooth structure. This is a therapeutic and restorative function performed directly on the patient's body.
- Device Description: The description details a material used for dental restorations, applied to the tooth.
- Lack of In Vitro Testing: While the performance studies include in vitro bench tests on the material itself (measuring properties like strength, wear, etc.), these are tests of the device, not tests performed by the device on a biological sample to provide diagnostic information.
- No Mention of Biological Samples: There is no indication that this device is used to examine or analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) for restorative purposes.
N/A
Intended Use / Indications for Use
TPH Spectra® + Universal Composite Restorative is indirect replacement of missing or deficient tooth structure in primary and permanent anterior and posterior teeth, e.g., 1. Direct anterior and posterior restorations (including occlusal surfaces) 2. Core build-ups 3. Splinting 4. Indirect restorations including inlays, onlays
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
primary and permanent anterior and posterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Radiopacity: 2.23 (0.08) mmAl
Fracture Toughness: 1.71 (0.16) MPa.m^(1/2)
Fluorescence: similar to a natural tooth.
Depth of Cure: 2.12 (0.02) mm
Flexural Strength: 117 (10) MPa
Flexural Modulus: 11.6 (0.8) MPa
Water Sorption: 19.3 (1.9) µg/mm³
Water Solubility: 0 µg/mm³
Localized Wear Loss: 0.47 (0.15) x10⁻² mm³
Sensitivity to Ambient Light: 180 s
Shade and Color Stability: Stable/Pass
Stain Resistance: 1.69 (0.25)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
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.
1
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,
Image /page/1/Picture/7 description: The image shows a signature that reads "Susan Runno DDS, MA". The signature is written in cursive with a black ink. The letters are connected and flow smoothly together.
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
2
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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3
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
Image /page/3/Picture/1 description: The image shows the Dentsply Sirona logo. The logo consists of a stylized leaf-like shape on the left and the words "Dentsply Sirona" on the right. The leaf shape is gray, and the text is a darker gray. The text is stacked, with "Dentsply" on top of "Sirona".
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.
4
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.
5
| Element | Predicate Device
Filtek™ Supreme Ultra Universal Restorative | Proposed Device
TPH Spectra® + Universal Composite
Restorative | Difference |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K083610 | To be assigned | |
| Indications
for 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 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 and veneers | "Direct or indirect replacement of
missing or deficient tooth structure
in primary and permanent anterior
and posterior teeth" is a description
of the indications in general.
Indications of the proposed device
are the same as the predicate device.
According to ISO 4049, the physical
property data support that the
proposed device meets the
requirements primarily for the direct
and indirect restorations. |
| Composition
of Materials | Methacrylate-based resin, photo initiator,
fillers and pigments. | Methacrylate-based resin, photo initiator,
fillers and pigments. | Chemically similar to the predicate
device. |
| Physical
Properties | Radiopacity: 2.10 (0.0) mmAl
Fracture Toughness: $1.64 (0.09) MPa.m^{1/2}$
Fluorescence: similar to a natural tooth.
Depth of Cure: 2.60 (0.02) mm
Flexural Strength: 131 (14) MPa
Flexural Modulus: 10.6 (0.6) MPa
Water Sorption: 33.1 (2.1) µg/mm³
Water Solubility: 1.0 (0.7) µg/mm³
Localized Wear Loss: 0.87 (0.24) x10⁻² mm³
Sensitivity to Ambient Light: 135 s
Shade and Color Stability: Stable/Pass
Stain Resistance: 3.30 (1.06) | Radiopacity: 2.23 (0.08) mmAl
Fracture Toughness: $1.71 (0.16) MPa.m^{1/2}$
Fluorescence: similar to a natural tooth.
Depth of Cure: 2.12 (0.02) mm
Flexural Strength: 117 (10) MPa
Flexural Modulus: 11.6 (0.8) MPa
Water Sorption: 19.3 (1.9) µg/mm³
Water Solubility: 0 µg/mm³
Localized Wear Loss: 0.47 (0.15) x10⁻² mm³
Sensitivity to Ambient Light: 180 s
Shade and Color Stability: Stable/Pass
Stain Resistance: 1.69 (0.25) | Physical property data support
substantial equivalence of the
proposed device when compared to
the predicate device. |
Table 5.1 Similarities and Differences between the proposed and the predicate devices
6
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).