(89 days)
No
The device description and performance studies focus on the material properties and physical performance of a dental composite restorative, with no mention of AI or ML.
No
The device is a restorative material used for filling cavities and defects, not a therapeutic device designed to treat or cure a disease.
No
The device description and intended use indicate that TPH Spectra® ST Flowable Composite Restorative is a restorative material used for filling cavities and defects, not for diagnosing conditions.
No
The device description clearly states it is a "visible light cured, radiopaque composite resin restorative material" and lists physical components like "methacrylate-based resin, photo initiator, silanated inorganic filler and pigments," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material used for direct restoration and repair of teeth, as well as related dental procedures. This is a therapeutic and restorative function performed directly on the patient's body.
- Device Description: The description details a composite resin material applied to the tooth structure. This is a physical material used for filling and bonding within the oral cavity.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the human body. IVDs are specifically designed for these purposes.
- Bench Tests: The performance studies described are bench tests evaluating the physical and chemical properties of the material (strength, hardness, radiopacity, etc.), not diagnostic performance metrics like sensitivity or specificity.
In summary, the TPH Spectra® ST Flowable Composite Restorative is a dental restorative material used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
TPH Spectra® ST Flowable Composite Restorative is indicated for:
- Direct restoration of cavities and lesions
- · Filling of defects and undercuts in crowns, inlays, and onlays
- Blockouts
- · Repair of defects
- · Pit and fissure sealants
- · Cementation of light transmissible indirect restorations
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
TPH Spectra® ST Flowable Composite Restorative is a visible light cured, radiopaque composite resin restorative material with flow characteristics that make it ideal for use in anterior and posterior 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.
TPH Spectra® ST Flowable Composite Restorative is applied to the tooth following use of a methacrylate-based dental adhesive and/or a cement, which bonds the restoration to the tooth structure.
TPH Spectra® ST Flowable Composite Restorative is packaged in multi-use dispensing packages and pre-dosed Compula® Tips for intraoral dispensing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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® ST Flowable Composite Restorative in accordance with ISO 10993-1(Biological Evaluation of Medical Devices- Part1: Evaluation and Testing), ISO 7405 (Dentistry - Evaluation of Biocompatibility of Medical Devices used in Dentistry) and FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility data support a conclusion that the TPH Spectra® ST Flowable Composite Restorative met the requirements of the following biological evaluations: Cytotoxicity Using the Colony Assay, ISO Intracutaneous Study, ISO Maximization Sensitization Test, Genotoxicity: Bacterial Reverse Mutation Study, Genotoxicity: Mouse Lymphoma Assay.
Physical Properties: In-vitro bench tests were performed on the TPH Spectra® ST Flowable Composite Restorative according to the requirements in ISO 4049: 2009 (Dentistry - Polymer-based restorative) and internal Dentsply Sirona internal criteria. Bench tests included: Compressive Strength, Flexural Strength, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Sensitivity to Ambient Light, Fracture Toughness, Localized Wear Volume Loss, Fluoride Ion Release Characterization, Shade and Color Stability, Film Thickness. The results from bench tests included in this premarket notification support the substantial equivalence of the TPH Spectra® ST Flowable Composite Restorative.
No data from human clinical studies has been included to support the substantial equivalence of the proposed device TPH Spectra® ST Flowable Composite Restorative.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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November 20, 2018
Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401
Re: K182288
Trade/Device Name: TPH Spectra ST Flowable Composite Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 21, 2018 Received: August 23, 2018
Dear Karl Nittinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary Mary S. S. Runner -S3 Date: 2018.11.20 Runner -S3 12:24:31 -05'00'
For 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) K182288
Device Name
TPH Spectra® ST Flowable Composite Restorative
Indications for Use (Describe) TPH Spectra® ST Flowable Composite Restorative is indicated for:
- Direct restoration of cavities and lesions
- · Filling of defects and undercuts in crowns, inlays, and onlays
- Blockouts
- · Repair of defects
- · Pit and fissure sealants
- · Cementation of light transmissible indirect restorations
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K182288 510(k) SUMMARY TPH Spectra® ST Flowable Composite Restorative
Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite eow York, PA 17401
Contact Person: Karl Nittinger Telephone Number: 717-849-4424 717-849-4343 Fax Number:
Date Prepared: August 21, 2018
Device Name:
- Proprietary Name: TPH Spectra® ST Flowable Composite .
- Restorative
- Classification Name: Tooth Shade Resin Material .
- CFR Number: ●
- 872.3690
-
. Device Class: Product Code: EBF .
Predicate Device:
| Company | Device | Predicate /
Reference | 510(k) | Product
Code |
|-----------------------------|------------------------|--------------------------|---------|-----------------|
| Shofu Dental
Corporation | Beautifil Flow
Plus | Predicate | K101603 | EBF |
| Dentsply
International | Flowable
Composite | Reference | K981965 | EMA |
Description of Device:
TPH Spectra® ST Flowable Composite Restorative is a visible light cured, radiopaque composite resin restorative material with flow characteristics that make it ideal for use in anterior and posterior 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.
4
TPH Spectra® ST Flowable Composite Restorative is applied to the tooth following use of a methacrylate-based dental adhesive and/or a cement, which bonds the restoration to the tooth structure.
TPH Spectra® ST Flowable Composite Restorative is packaged in multi-use dispensing packages and pre-dosed Compula® Tips for intraoral dispensing.
Indications for Use:
TPH Spectra® ST Flowable Composite Restorative is indicated for:
- Direct restoration of cavities and lesions ●
- Filling of defects and undercuts in crowns, inlays, and onlays ●
- Blockouts
- Repair of defects ●
- Pit and fissure sealants ●
- Cementation of light transmissible indirect restorations ●
Substantial Equivalence:
Technological Characteristics:
Information provided in this 510(k) submission supports the substantial equivalence of TPH Spectra® ST Flowable Composite Restorative when compared to the predicate device, Beautifil Flow Plus (K101603), and the reference device, Flowable Composite (K981965), in terms of intended use, indications for use, composition, physical properties and technological characteristics. The subject device has similar indications for use as those cleared for the predicate device (K101603). Both are indicated for direct restoration of cavities and lesions, as well as, repairs. The reference device (K981965), which, like the subject device, is also a methacrylate-based flowable composite material, is included in support of substantial equivalence as it is cleared for the; filling of defects and undercuts in crowns, inlays, and onlays; blockouts; and pit and fissures sealant indications as are included in the indications for use of the subject TPH Spectra® ST Flowable Composite Restorative.
As a tooth shade resin material classified under 21 CFR 872.3690, the subject TPH Spectra® ST Flowable Composite Restorative has the same intended use as the predicate Beautiful Flow Plus (K101603). The subject TPH Spectra® ST Flowable Composite Restorative incorporates the same fundamental technology (low-viscosity, methacrylate-based composite resin) and its physical properties conform to the same recognized consensus standard as do the properties of the predicate device (K101603).
Tables 5.1 and 5.2 are presented in teh following pages to summarize the indicaitions for use and technical comparison of the subect TPH Spectra® ST Flowable Composite Restorative to the precdicate and reference devices.
5
Table 5.1-Comparison of the proposed TPH Spectra® ST Flowable Composite Restorative and the Predicate Device, Beautifil Flow Plus (K101603)
| Proposed Device
TPH Spectra® ST Flowable
Composite Restorative | Predicate Device
Beautifil Flow Plus
(K101603) | Differences |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use:
• Direct restoration of cavities and
lesions
• Filling of defects and undercuts
in crowns, inlays, and onlays
• Blockouts
• Repair of defects
• Pit and fissure sealants
• Cementation of light
transmissible indirect restorations | Indications for Use:
• Beautifil Flow Plus is a light-
curing dental filling material
having low viscosity
intended to directly restore
cavities and lesions (except
for root canal filling), and to
repair fractured artificial
crowns. | The Indications for Use of the proposed device are similar to the
predicate device.
"Filling of defects and undercuts in crowns, inlays, and onlays" and
"Blockouts" are not specific indications for use of the primary
predicate device. However, the reference device is included in
support of substantial equivlance, incorporates the same technology
as the subject device, and includes these indications.
"Repair of defects" is a general description of all direct or indirect
repairs, e.g. repair of fractured artificial crowns in the predicate device.
"Pit and fissure sealants" and "Cementation of light transmissible
indirect restorations" are not the indications of this predicate device. |
| Composition of Materials:
Methacrylate-based resins, photo
initiators, fillers and pigments. | Composition of Materials:
Methacrylate-based resins,
photo initiators, fillers and
pigments. | Chemically similar to the predicate device. |
| Physical Properties:
Meet ISO 4049:2009 requirements. | Physical Properties:
Meet ISO 4049:2009
requirements. | Physical Property data similar to the predicate device. |
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Table 5.2-Comparison of the proposed TPH Spectra® ST Flowable Composite Restorative and the reference device, Flowable Composite (K981965)
| Proposed Device
(K981965) | Reference Device
(K981965) | Differences |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TPH Spectra® ST Flowable
Composite Restorative | Flowable Composite | |
| Indications for Use:
• Direct restoration of cavities
and lesions
• Filling of defects and
undercuts in crowns, inlays,
and onlays
• Blockouts
• Repair of defects
• Pit and fissure sealants
• Cementation of light
transmissible indirect
restorations | Indications for Use:
• Filling of defects and undercuts in
crowns, inlays and onlays
• Liner under direct restorative
materials and under inlay
restorations – Class II box liner
• Tunnel preparations
• Pit and fissure sealants
• Amalgam margin repair
• Improving margins of acrylic
temporaries
• Small Class IV repairs
• Intraoral porcelain repair
• Cementing porcelain veneers,
crowns, inlays/onlays
• Refacing acrylic temporaries
• Blockouts
• Covering incisal edge stains
• Repair of small enamel defects
• Provisional occlusal changes
• Class III, V restorations
• Conservative Class I restorations
• Margin correction / adjustment of
composite crowns for indirect
laboratory use | The Indications for Use of the proposed device is similar to the
reference device.
"Direct restoration of cavities and lesions" is a general description
of all direct restoration indications of the reference device. Class I,
Class II and Class IV restorations are not the indications of this
reference device.
"Repair of defects" is a general description of all direct or indirect
repair indications of the reference device. |
| Composition of Materials: | Composition of Materials: | Chemically similar to the reference device. |
| Methacrylate-based resins, photo
initiators, fillers and pigments. | Methacrylate-based resins, photo
initiators, fillers and pigments. | |
| Physical Properties: | Physical Properties: | Physical Property data similar to the reference device. |
| Meet ISO 4049:2009
requirements. | Meet ISO 4049:2009 requirements. | |
7
Biocompatibility Testing:
An evaluation of biocompatibility was performed for the TPH Spectra® ST Flowable Composite Restorative in accordance with ISO 10993-1(Biological Evaluation of Medical Devices- Part1: Evaluation and Testing), ISO 7405 (Dentistry - Evaluation of Biocompatibility of Medical Devices used in Dentistry) and FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". In support of substantial equivalence, biocompatibility test data on the TPH Spectra® ST Flowable Composite Restorative have been included. The biocompatibility data support a conclusion that the TPH Spectra® ST Flowable Composite Restorative met the requirements of the following biological evaluations:
- Cytotoxicity Using the Colony Assay
- ISO Intracutaneous Study ●
- ISO Maximization Sensitization Test
- Genotoxicity: Bacterial Reverse Mutation Study ●
- Genotoxicity: Mouse Lymphoma Assay ●
Physical Properties:
In-vitro bench tests were performed on the TPH Spectra® ST Flowable Composite Restorative according to the requirements in ISO 4049: 2009 (Dentistry - Polymer-based restorative) and internal Dentsply Sirona internal criteria.
Bench tests included in support of the substantial equivalence of TPH Spectra® Flowable Composite Restorative are:
- . Compressive Strength
- Flexural Strength ●
- Surface Hardness ●
- Radiopacity
- Water Sorption ●
- Water Solubility ●
- Sensitivity to Ambient Light ●
- Fracture Toughness ●
- Localized Wear Volume Loss ●
- Fluoride Ion Release Characterization ●
- Shade and Color Stability ●
- Film Thickness .
The results from bench tests included in this premarket notification support the substantial equivalence of the TPH Spectra® ST Flowable Composite Restorative.
8
Clinical Performance Data:
No data from human clinical studies has been included to support the substantial equivalence of the proposed device TPH Spectra® ST Flowable Composite Restorative.
Conclusion Regarding Substantial Equivalence:
The similarities in technology and indications for use, together with results of non-clinical performance testing and biocompatibility testing, support that TPH Spectra® ST Flowable Composite is substantially equivalent to the predicate devices.