The subject Surefil one™ Self-adhesive Composite Hybrid is an self- adhesive dental restorative material which is intended to be used as a restorative filling material for direct restorations. The "composite hybrid" composition of the subject device is based on resin-modified glass ionomer chemistry and is provided in a powder/liquid formulation in a mixing capsule.

The subject Surefil one™ Self-adhesive Composite Hybrid offers is available in multiple shades and exhibits the following features:

Self-adhesiveness to enamel and dentin
Fluoride release
Bulk fill and dual-cure
Radiopacity (equivalent to 2mm aluminum).

AI/ML Overview

The provided text describes the Dentsply Sirona Surefil one™ Self-adhesive Composite Hybrid, a dental restorative material, and its substantial equivalence determination by the FDA based on non-clinical performance data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test. Instead, it states that the performance "satisfactorily met the requirements" and that the device "conforms to the requirements" of the standards. The reported device performance is presented as meeting these standards.

Test Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Performance Data	Complies with ISO 9917-2:2017 and internal Dentsply Sirona criteria.
Compressive strength	Satisfactorily met requirements	Met requirements
Flexural strength	Satisfactorily met requirements	Met requirements
Setting time	Satisfactorily met requirements	Met requirements
Radio-opacity	Satisfactorily met requirements	Met requirements
Shear bond strength to enamel	Satisfactorily met requirements	Met requirements
Shear bond strength to dentin	Satisfactorily met requirements	Met requirements
Shear bond strength to composite	Satisfactorily met requirements	Met requirements
Enamel wear (including ACTA wear test)	Satisfactorily met requirements	Met requirements
Biocompatibility	Complies with EN ISO 10993-1.
Cytotoxicity testing	Satisfactorily met requirements	Met requirements
Chemical analysis of leachable organic and inorganic compounds	Satisfactorily met requirements	Met requirements

2. Sample Size Used for the Test Set and Data Provenance

The document states that "In-vitro bench tests were performed" and "Comparartive tests were performed between the proposed Surefil one™ Self-adhesive Composite Hybrid and the predicate device (K130223)". However, the specific sample sizes used for each test are not provided in this document. The data provenance is described as non-clinical in-vitro bench tests conducted by Dentsply Sirona, referencing ISO 9917-2:2017 and EN ISO 10993-1. There is no information about country of origin of the data beyond "internal Dentsply Sirona criteria". The data is prospective for the purpose of this submission (i.e., new tests were performed).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this study involves non-clinical in-vitro bench testing of physical and chemical properties of a dental restorative material, the concept of "experts used to establish ground truth" as it would apply to diagnostic imaging or clinical decisions is not directly applicable. The "ground truth" for these tests is based on established international standards (ISO, EN ISO) and internal company criteria, which are derived from scientific principles and industry best practices for material characterization. No information on human experts establishing ground truth for these in-vitro tests is provided.

4. Adjudication Method for the Test Set

As explained above, since the study involves non-clinical in-vitro bench testing, an adjudication method for human-read interpretations is not applicable or mentioned. The results of these tests are objective measurements against predefined criteria/standards.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical bench study comparing the physical and chemical properties of the device against a predicate and established standards, not an evaluation of human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done in the sense that the device's performance was evaluated independently through in-vitro bench tests. This refers to the algorithm/device itself (the dental material in this case) and its intrinsic properties, without human-in-the-loop performance measurement.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests is based on scientific measurement against established international standards (e.g., ISO 9917-2:2017, EN ISO 10993-1) and internal Dentsply Sirona criteria. This is essentially an objective, measured characteristic rather than an expert consensus, pathology, or outcomes data in the traditional medical device sense.

8. Sample Size for the Training Set

This document describes a premarket notification for a physical medical device (dental restorative material), not an AI/ML-driven device that requires training data. Therefore, the concept of a "training set" and its sample size is not applicable to this submission.

9. How the Ground Truth for the Training Set Was Established

As stated above, a training set is not applicable to this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 23, 2020

Dentsply Sirona Karl Nittinger Vice President Corporate Regulatory Affairs 221 W Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K192530

Trade/Device Name: Surefil one™ Self-adhesive Composite Hybrid Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: December 24, 2019 Received: December 26, 2019

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192530

Device Name Surefil one™ Self-adhesive Composite Hybrid

Indications for Use (Describe) Class I to Class V restorations Core build up

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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Traditional 510(k)- Surefil one Self-adhesive Composite Hybrid

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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is a dark gray color.

510(k) SUMMARY

For: K192530

Surefil one™ Self-adhesive Composite Hybrid

1. Submitter Information:

Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Contact Person: Karl Nittinger Email: karl.nittinger@dentsplysirona.com Telephone Number: 717-849-4424 Fax Number: 717-849-4343

Date Prepared:

20 December 2019

Dental cement

Surefil one™ Self-adhesive Composite Hybrid

2. Device Name:

Proprietary Name: .
Classification Name: ●
CFR Number: ●
Device Class: ●
Product Code: .
EMA

872.3275

Predicate Device: 3.

Predicate Device	510(k)	Company Name
Primary Predicate:Pulpdent RMGI FILL	K130223	Pulpdent Corporation
Reference Device	510k)	Company Name
Secondary Predicate:GC Fuji Direct	K172382	GC America Inc.

1. Description of Device:
  The subject Surefil one™ Self-adhesive Composite Hybrid is an self- adhesive dental restorative material which is intended to be used as a restorative filling material for direct restorations. The "composite hybrid" composition of the subject device is based on resin-modified glass ionomer chemistry and is provided in a powder/liquid formulation in a mixing capsule.

The subject Surefil one™ Self-adhesive Composite Hybrid offers is available in multiple shades and exhibits the following features:

· Self-adhesiveness to enamel and dentin
· Fluoride release
· Bulk fill and dual-cure
· Radiopacity (equivalent to 2mm aluminum).

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5. Indications for Use:

Class I to Class V restorations
. Core build up
Substantial Equivalence: 6.

Technological Characteristics

Proposed DeviceSurefil one™Self-adhesiveComposite HybridK192530	Primary PredicateDevicePulpdent RMGI FILLK130223	Reference DeviceGC Fuji DirectK172382	Differences
Indications for Use:• Class I to ClassV restorations• Core build up	Indications for Use:Resin-modified glassionomer preparationused by dentalprofessionals as fillingmaterial in dentalrestorations	Indications for Use:1. Class III and V restorations2. Restoration of primary teeth3. Core build-up4. Cases where radiopacity isrequired5. Base material for Class I andClass II cavities using asandwich laminate technique	The verbiage describing the indicationsfor Use of Surefil one™ Self-adhesiveComposite Hybrid and the primarypredicate, Pulpdent RMGI FILL isdifferent. The wording used by theprimary predicate (namely: "as fillingmaterial in dental restorations")describes a much broader field.The reference device indications whencompared to the proposed Surefilone™ Self-adhesive Composite Hybridlists the cavity classes and the corebuild-up, respectively.
Features:	Features:
Self-adhesive compositehybrid restorative	Resin-modified glassionomer(self-adhesive since nouse of dental adhesive isrequired according to theInstructions for Use)	Resin-modified glass ionomer(No need for etchant and adhesive)	Composite hybrid restorative is basedon resin-modified glass ionomerchemistry. By its chemistry, resinmodified glass-ionomers exhibit self-adhesive properties to enamel anddentin.
Proposed DeviceSurefil one™Self-adhesiveComposite HybridK192530	Primary PredicateDevicePulpdent RMGI FILLK130223	Reference DeviceGC Fuji DirectK172382	Differences
Powder/liquidformulation in a mixingcapsule	Paste/paste formulationin a double-chambersyringe	Paste/paste formulation in a double-chamber syringe.	The final delivery form of the proposeddevice into the teeth is a paste and thereforethe same as the predicate devices.
Triple cure- Light-curing- Self-curing- Acid-basereaction	Triple cure- Light-curing- Self-curing- Acid-base	Acid-base reaction and polymerization ofmethacrylate monomers through dual cure	No difference between the proposed deviceand the primary predicate device. Thereference only has dual cure feature.
Fluoride release	Release calcium,phosphate and fluoride	Bioactive material with high fluoriderelease	Release of calcium, release of phosphateions and bioactive material are not aproposed feature for the subject device,Surefil one™ Self- adhesive CompositeHybrid device.
Sterility:Non-sterile when used.	Sterility:Non-sterile when used	Sterility:Non-sterile when used	Sterility of the proposed device is identicalto the predicate and reference devices.
Storage Temp:2°C - 24°C	Storage Temp:"Cool room temperature" *	Storage Temp:4°C - 25°C	Storage temperature differs for the proposeddevice compared to the predicate andreferenced devices. Test data is included tosupport that proposed device meets its identifiedrequirements when stored within the identifiedtemperature range.
Shelf Life:10 months	Shelf Life:2 years*	Shelf Life:2 years	The initial shelf life of the proposed device ismore limited than that of the predicate andreference devices. Shelf life data is included toverify that the proposed device meets itsidentified requirements throughout the proposedshelf life.
Available Shades:A1, A2, A3, A3.5, Bleach White	Available Shades*:A1, A2, A3, A3.5	Available Shades:A1, A2, A3	The proposed device is offered in identicalshades as the predicate with the addition ofbleach white.
Application System:Pre-dosed capsule andextruder.	Application System:Dual chamber syringe	Application System:Direct dispensed or manual application aftermixing.	Proposed, predicate and reference devices canbe direct dispensed.
* Obtained from publicly available labeling.

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7. Non-Clinical Performance Data:

In-vitro bench tests were performed on the Surefil one™ Self-adhesive Composite Hybrid according to the requirements in ISO 9917-2:2017 (Dentistry -Water based cements - part 2: Resin-modified cements) and internal Dentsply Sirona criteria.

Bench tests included in support of substantial equivalence of Surefil one™ Selfadhesive Composite Hybrid. Compartative tests were performed between the proposed Surefil one™ Self-adhesive Composite Hybrid and the predicate device (K130223). A summary list of testing conducted in support of substantial equivalence is as follows:

Compressive strength ●
Flexural strength ●
Setting time
Radio-opacity ●
Shear bond strength to enamel ●
Shear bond strength to dentin
Shear bond strength to composite ●
Enamel wear ●
. ACTA (Academic Center for Dentistry Amsterdam) wear test

The performance of the Surefil one™ Self-adhesive Composite Hybrid satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.

Cytotoxicity testing was performed for Surefil one™ Self-adhesive Composite Hybrid as well as chemical analysis of leachable organic and inorganic compounds in compliance with the standard EN ISO 10993-1. The results of the biocompatibility testing and chemical analysis conducted relating to the subject Surefil one™ Self-adhesive Composite Hybrid support its substantial equivalence.

8. Clinical Performance Data

No data from human clinical studies has been included to support the substantial equivalence of the Surefil one™ Self-adhesive Composite Hybrid.

9. Conclusion Regarding Substantial Equivalence

The Surefil one™ Self-adhesive Composite Hybrid has the same intended use and has similar indications for use as the primary predicate Pulpdent RMGI FILL (K130223) and the secondary predicate GC Fuji Direct (K172382). Test data to verify the performance of the Surefil one™ Self-adhesive Composite Hybrid has been provided including: compressive and flexural strength, adhesion to enamel, dentin and composite, setting time, ACTA (Academic Center for Dentistry Amsterdam) wear, enamel wear and radio-opacity and the results of this testing, combined with the design and intended use comparison with the primary predicate device, support substantial equivalence.

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.