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.

AI/ML Overview

The provided text is a 510(k) summary for the TPH Spectra® ST Flowable Composite Restorative. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not describe a study that uses a device to meet acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or an AI algorithm's performance.

Instead, it pertains to a dental restorative material and its acceptance criteria are related to physical properties and biocompatibility as per established international standards for dental materials.

Therefore, I cannot provide the information requested in your prompt based on the given document, as it outlines the regulatory clearance process for a material rather than the performance evaluation of a diagnostic or AI-driven medical device.

Key points from the document indicating why it doesn't fit your request:

Device Type: The device is a "Tooth Shade Resin Material" (flowable composite restorative), not a diagnostic device or an AI algorithm.
Acceptance Criteria Focus: The criteria are related to material science (biocompatibility, compressive strength, flexural strength, radiopacity, water sorption, etc.) and adherence to ISO standards (ISO 4049:2009, ISO 10993-1, ISO 7405).
No Clinical Performance Data: The document explicitly states, "No data from human clinical studies has been included to support the substantial equivalence of the proposed device TPH Spectra® ST Flowable Composite Restorative." This confirms there's no performance study in humans for diagnostic accuracy.
No AI Component: There is no mention of an AI component or algorithm.

Therefore, I cannot populate the table or answer the specific questions about test set sample size, ground truth, expert qualifications, MRMC studies, or standalone performance, as these are not relevant to the evaluation described in the provided 510(k) summary.

Summary

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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

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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

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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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Image /page/3/Picture/0 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a curved leaf or wave in gray. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, both in a simple, sans-serif font and in the same gray color as the abstract shape.

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)	ProductCode
Shofu DentalCorporation	Beautifil FlowPlus	Predicate	K101603	EBF
DentsplyInternational	FlowableComposite	Reference	K981965	EMA

Description of Device:

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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.

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Table 5.1-Comparison of the proposed TPH Spectra® ST Flowable Composite Restorative and the Predicate Device, Beautifil Flow Plus (K101603)

Proposed DeviceTPH Spectra® ST FlowableComposite Restorative	Predicate DeviceBeautifil Flow Plus(K101603)	Differences
Indications for Use:• Direct restoration of cavities andlesions• Filling of defects and undercutsin crowns, inlays, and onlays• Blockouts• Repair of defects• Pit and fissure sealants• Cementation of lighttransmissible indirect restorations	Indications for Use:• Beautifil Flow Plus is a light-curing dental filling materialhaving low viscosityintended to directly restorecavities and lesions (exceptfor root canal filling), and torepair fractured artificialcrowns.	The Indications for Use of the proposed device are similar to thepredicate device."Filling of defects and undercuts in crowns, inlays, and onlays" and"Blockouts" are not specific indications for use of the primarypredicate device. However, the reference device is included insupport of substantial equivlance, incorporates the same technologyas the subject device, and includes these indications."Repair of defects" is a general description of all direct or indirectrepairs, e.g. repair of fractured artificial crowns in the predicate device."Pit and fissure sealants" and "Cementation of light transmissibleindirect restorations" are not the indications of this predicate device.
Composition of Materials:Methacrylate-based resins, photoinitiators, fillers and pigments.	Composition of Materials:Methacrylate-based resins,photo initiators, fillers andpigments.	Chemically similar to the predicate device.
Physical Properties:Meet ISO 4049:2009 requirements.	Physical Properties:Meet ISO 4049:2009requirements.	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 FlowableComposite Restorative	Flowable Composite
Indications for Use:• Direct restoration of cavitiesand lesions• Filling of defects andundercuts in crowns, inlays,and onlays• Blockouts• Repair of defects• Pit and fissure sealants• Cementation of lighttransmissible indirectrestorations	Indications for Use:• Filling of defects and undercuts incrowns, inlays and onlays• Liner under direct restorativematerials and under inlayrestorations – Class II box liner• Tunnel preparations• Pit and fissure sealants• Amalgam margin repair• Improving margins of acrylictemporaries• 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 ofcomposite crowns for indirectlaboratory use	The Indications for Use of the proposed device is similar to thereference device."Direct restoration of cavities and lesions" is a general descriptionof all direct restoration indications of the reference device. Class I,Class II and Class IV restorations are not the indications of thisreference device."Repair of defects" is a general description of all direct or indirectrepair indications of the reference device.
Composition of Materials:	Composition of Materials:	Chemically similar to the reference device.
Methacrylate-based resins, photoinitiators, fillers and pigments.	Methacrylate-based resins, photoinitiators, fillers and pigments.
Physical Properties:	Physical Properties:	Physical Property data similar to the reference device.
Meet ISO 4049:2009requirements.	Meet ISO 4049:2009 requirements.

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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.

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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.

Regulation Number and Section

§ 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.