Dentsply Sirona Universal Spray Glazes are aerosol glazing porcelains used to glaze high-strength glass ceramic and zirconia dental restorations. The glaze sprays are applied to restorations and fired.

Device Description

The proposed devices, Dentsply Sirona Universal Spray Glazes are sprayable glazing porcelains, intended for glazing the surface of dental restorations. The glazes are supplied to dental professionals in an aerosol can. Different variations of glazes are available to meet the aesthetic preferences of dental professionals and patients. Variations with or without fluorescing agent come in a ready-to-use spray can. Variations are distinguished by the names, "Fluo" or "No Fluo" to designate the presence of fluorescing agents in the product.

No mixing is required by dental professionals as different glaze options (with or without fluorescing agent) are supplied to dental professionals in a ready-to-use form. The addition of the fluorescing agent contributes to a more aesthetic natural looking restoration.

The proposed devices, Dentsply Sirona Universal Spray Glazes, are applied on the surface of the dental restoration (example: fixed dental prostheses such as crown or bridge) in a thinuniform layer. After initial application, the restoration is then fired in a furnace for further processing. An additional layer of the proposed Dentsply Sirona Universal Spray Glazes can be applied after first firing, if necessary. If additional layer is applied, the dental restoration is placed again in the dental furnace for final firing.

AI/ML Overview

This document is a 510(k) Premarket Notification for Dentsply Sirona Universal Spray Glazes. It focuses on demonstrating substantial equivalence to a predicate device, CEREC SpeedGlaze (K160099), for dental glazing purposes. The provided information does not describe a study that uses an AI/ML algorithm or requires a detailed ground truth establishment process involving multiple experts.

The acceptance criteria provided and the study conducted are for a physical material (dental glaze), not an AI/ML device. Therefore, many of the requested bullet points for an AI/ML study (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract the relevant information from the document regarding the acceptance criteria and the performance study undertaken for this dental glaze product.

Here's a breakdown of the requested information based on the provided document, highlighting what is applicable and what is not:

Device Name: Dentsply Sirona Universal Spray Glazes

Device Type: Aerosol glazing porcelains for dental restorations (a physical material, not an AI/ML device).

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are derived from the ISO 6872:2015 - Dentistry - Ceramic materials standard for Type I Class 1 materials. The reported device performance is stated as meeting these criteria.

ISO 6872 Test Requirement	Acceptance Criteria (ISO 6872:2015 Type I Class 1)	Reported Device Performance (Dentsply Sirona Universal Spray Glazes)	Predicate Device Performance (CEREC SpeedGlaze K160099)
Uniformity	Visual inspection	Meets criteria	Not reported
Freedom from extraneous material	Visual inspection	Meets criteria	Not reported
Linear Thermal Expansion Coefficient, CTE	No specification limit; Acceptance criteria is defined as: The coefficient of thermal expansion shall not deviate by more than 0.5 x 10⁻⁶ K⁻¹ from the value stated by the manufacturer. (The specific stated value for the proposed device is not explicitly listed, but it meets the requirement relative to its own stated value.)	Meets criteria	7.5 x 10⁻⁶ K⁻¹ ± 0.5 x 10⁻⁶ K⁻¹
Glass Transition Temperature	No specification limit; Acceptance criteria is defined as: The glass transition temperature shall not deviate by more than 20°C from the value stated by the manufacturer. (The specific stated value for the proposed device is not explicitly listed, but it meets the requirement relative to its own stated value.)	Meets criteria	490° C ± 10°C
Flexural Strength	50 MPa min.	Meets criteria (>50 MPa)	>50 MPa
Chemical Solubility	< 100 µg/cm² min	Meets criteria (<100 µg/cm²)	<100 µg/cm²
Radioactivity	< 1 Bq/g U²³⁸	Meets criteria (<1 Bq/g U²³⁸)	<1 Bq/g U²³⁸

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly quantified in terms of number of "samples" for each test. The document states "The test samples used for performance testing included highest possible % of the components." This implies material batches rather than a statistical sample size for an AI/ML test set.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or for Dentsply Sirona. It appears to be prospective testing specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical materials test against ISO standards, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is defined by the ISO 6872:2015 standard itself.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. See point 3.

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-assisted device. No human reader studies or MRMC studies were conducted as part of this submission for this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical material, not an algorithm.

7. The type of ground truth used:

Standard-based performance: The "ground truth" (or more accurately, the performance benchmark) is defined by the internationally recognized standard ISO 6872:2015 - Dentistry - Ceramic materials. The device's physical and chemical properties are tested against the specifications (acceptance criteria) outlined in this standard for Type I Class 1 materials.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device and does not have a "training set."

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary of the Study:

The study conducted to prove the device meets the acceptance criteria was primarily a non-clinical performance testing of physical and chemical properties. The Dentsply Sirona Universal Spray Glazes were tested according to the requirements of the ISO 6872 - Dentistry - Ceramic materials standard (specifically ISO 6872:2015 for Type I Class 1 materials). The document states that the proposed device "meets criteria" for all specified tests, including uniformity, freedom from extraneous material, linear thermal expansion coefficient, glass transition temperature, flexural strength, chemical solubility, and radioactivity. The test samples used were formulated with the "highest possible % of the components," including fluorescing agents, to ensure representative testing. Biocompatibility was also assessed through an analysis and confirmatory cytotoxicity test (ISO 10993-5), supported by reference to existing device formulations. No human clinical studies were performed. The conclusion of the submission is that the proposed device is substantially equivalent to the predicate device (CEREC SpeedGlaze) based on shared intended use, similar fundamental technology, major components, and equivalent performance against the same ISO standard.

Summary

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January 20, 2021

Dentsply Sirona Karl Nittinger Director, Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

Re: K202629

Trade/Device Name: Dentsply Sirona Universal Spray Glazes Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 21, 2020 Received: October 22, 2020

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 Michael Adjodha Assistant 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)

K202629

Device Name Dentsply Sirona Universal Spray Glazes

Indications for Use (Describe)

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

Image /page/3/Picture/1 description: The image contains the logo for Dentsply Sirona. The logo consists of a stylized, abstract symbol on the left, resembling a curved shape with a gap in the middle. To the right of the symbol is the text "Dentsply Sirona" in a simple, sans-serif font. The text is arranged with "Dentsply" on the top line and "Sirona" on the bottom line.

510(k) SUMMARY K202629

Dentsply Sirona Universal Spray Glazes

1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Contact Person:	Karl Nittinger
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: January 6, 2021

1. Device Name:
  ●

Proprietary Name: Dentsply Sirona Universal Spray Glazes Classification Name:
=
Porcelain powder for clinical use
. CFR Number:
21 C.F.R. 872.6660
Device Class: ●
EIH Product Code: .
1. Predicate Device:

Primary Predicate Device	510(k)	Company Name
CEREC SpeedGlaze	K160099	Sirona Dental SystemsGmbH

Reference Devices:

(Reference devices are included to support the biocompatibility of the proposed devices.)

Reference Devices	510(k)	Company Name
Quattro PorcelainSystem	K091706	Dentsply Sirona
Celtra Press	K161269	Dentsply Sirona
PFZ Porcelain System	K033553	Dentsply Sirona
Cercon Ceram S	K022796	Dentsply Sirona
Duceram Plus CeramicSystem	K040420	DeguDent GmbH

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4. Description of Device:

5. Indications for Use:

Dentsply Sirona Universal Spray Glazes are aerosol glazing used to glaze highstrength glass ceramic and zirconia dental restorations. The glaze sprays are applied to restorations and fired.

6. Substantial Equivalence:

For the purpose of substantial equivalence, the proposed device, Dentsply Sirona Universal Spray Glazes is compared to the legally marketed predicate device CEREC SpeedGlaze (K160099) manufactured by Sirona Dental Systems GmbH.

The proposed device Dentsply Sirona Universal Spray Glazes are intended for glazing the surface of dental restorations and thereby have the same intended use as the predicate device CEREC SpeedGlaze (K160099).

Both the predicate and proposed devices have been tested to applicable requirements of ISO 6872 - Dentistry - Ceramic materials.

Table 5.1. details the similarities and differences between the proposed and predicate devices

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Table 5. 1Element	Proposed DeviceDentsply Sirona UniversalSpray Glazes	Primary Predicate DeviceCEREC SpeedGlaze	Similarities and Differences
510(k)	K202629	K160099	N/A
Indications for use	Dentsply Sirona Universal SprayGlazes are aerosol glazingporcelains used to glaze high-strength glass ceramic andzirconia dental restorations. Theglaze sprays are applied torestorations and fired.	Glazing of individually designeddental restorations from dentalceramics.The CEREC SpeedGlaze Sprayis used for coating dentalrestorations made from SironaCAD/CAM materials. It isadministered extra-orally and isindicated for crowns, inlays,onlays, partial crowns andbridges in the anterior andposterior tooth region.	☐ Both the proposed device DentsplySirona Universal Spray Glazes andpredicate device CEREC SpeedGlaze(K160099) have similar indications foruse and identical intended use as glazingmaterials. Both devices are aerosolsprays designed for glazing dentalrestorations.☐ The predicate device CERECSpeedGlaze further details the use byincluding the types of dental restorationsthat can be glazed such as crowns,inlays, etc. The proposed deviceDentsply Sirona Universal Spray Glazeshave the same use but is wordeddifferently for simplification purposes.The proposed Dentsply Sirona UniversalSpray Glazes are marketed to dentalprofessionals. Types of dentalrestorations are covered under ISO6872:2015 for Type I Class 1 materials.This is well-known within the dentalindustry and does not need to beexplicitly stated within the indicationsstatement.
Table 5. 1	Proposed Device	Primary Predicate Device
Element	Dentsply Sirona UniversalSpray Glazes	CEREC SpeedGlaze	Similarities and Differences
510(k)	K202629	K160099	N/A
Composition	Major components: oxidesDevice contains organiccomponents and propellent that isburned-off during the firingprocess and is not included in thefinal device.	Major components: oxidesDevice contains organiccomponents and propellent that isburned-off during the firingprocess and is not included in thefinal device.	Both devices have similar composition for major components. The organic components and propellent gas are not relevant as they burn-off without residue during firing process. Minor changes in components have been made to the proposed device Dentsply Sirona Universal Spray Glazes to offer different variations (with and without fluorescing agent).
Application	The glaze is applied by sprayingon to the surface of the dentalrestorations and a firing processis carried out in a dental furnace.	The glaze is applied by sprayingon to the surface of the dentalrestorations and a firing processis carried out in a dental furnace.	Same.
Physical properties	ISO 6872 – Dentistry - Ceramicmaterials Type 1 Class 1materials	ISO 6872 - Dentistry - CeramicmaterialsType 1, Class 1A materials	Both devices have similar physical properties as glazing materials. Note: there are no specification differences between class 1A and Class 1 (A and B) materials per ISO 6872 standard.
Packaging components	Packaged in a spray can withсар.	Packaged in a spray can withсар.	All packaging components are the same.
Shelf life / Storage	3.5 yearsAvoid exposure to temperaturesexceeding 50°C / 122 °F.	3.5 yearsAvoid exposure to temperaturesexceeding 50°C / 122 °F.	Same.

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1. Non-Clinical Performance Data
  Physical Properties:

The proposed device, Dentsply Sirona Universal Spray Glazes, and the predicate device, CEREC SpeedGlaze (K160099), have been tested per ISO 6872 - Dentistry - Ceramic materials.

The test samples used for performance testing included highest possible % of the components. The test samples contained fluorescing agent at the highest possible % despite not having any effect on the performance testing. Data derived from testing is included to support the conclusion that the proposed device Dentsply Sirona Universal Spray Glaze is equivalent to the predicate device CEREC SpeedGlaze (K160099).

Table 5.2. Summary of similarities and differences between the proposed and predicate devices

Table 5.2 ISO 6872 Test Requirement of the proposed and predicate devices
ISO 6872 TestRequirement	Proposed DeviceDentsply Sirona	Predicate DeviceCEREC SpeedGlaze	Specification limitISO 6872:2015
	Universal SprayGlazes	K160099*	Type I Class 1
Uniformity	Meets criteria	Not reported	Visual inspection
Freedom fromextraneous material	Meets criteria	Not reported	Visual inspection
Linear ThermalExpansion Coefficient,CTE	Meets criteria	$7.5 x 10^{-6} K^{-1} ± 0.5 x$$10^{-6} K^{-1}$	No specification limitAcceptance criteria is definedas: The coefficient of thermalexpansion shall not deviate bymore than 0.5 x $10^{-6}K^{-1}$ from thevalue stated by themanufacturer
Glass TransitionTemperature	Meets criteria	490° C ± 10°C	No specification limitAcceptance criteria is definedas: The glass transitiontemperature shall not deviate bymore than 20°C from the valuestated by the manufacturer
Flexural Strength	Meets criteria>50 MPa	>50 MPa	50 MPa min.
Chemical Solubility	Meets criteria<100µg/cm²	<100µg/cm²	< 100µg/cm² min
Radioactivity	Meets criteria$<1 Bq/g U^{238}$	$<1 Bq/g U^{238}$	$<1 Bq/g U^{238}$

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Biocompatibility:

An analysis is included to support the biocompatibility of the proposed device Dentsply Sirona Universal Spray Glazes and its equivalency to the predicate device CEREC SpeedGlaze (K160099). Additional support for biocompatibility included reference to formulation components comprising the reference devices listed in Section 3 of this 510(k) Summary. Confirmatory cytotoxicity test results further support the biocompatibility of the proposed device Dentsply Sirona Universal Spray Glazes conducted in accordance with ISO 10993-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity. The test samples used for the biocompatibility testing included highest possible % of the components inclusive of fluorescing agents.

8. Clinical Performance Data

No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Dentsply Sirona Universal Spray Glazes.

9. Conclusion Regarding Substantial Equivalence

The proposed device Dentsply Sirona Universal Spray Glazes and the predicate device CEREC SpeedGlaze are intended for use as glazing materials. The proposed device has the same intended use as a glazing materials, incorporates the same fundamental technology and has similar major components as the predicate device CEREC SpeedGlaze, K160099.

Both the predicate and proposed devices have similar technological characteristics and were tested to the same ISO 6872:2015 (Dentistry-Ceramic materials) standard and met the same specification requirements of Type I Class 1 materials.

Both the predicate and proposed devices have same packaging components. Spray can / cap are composed of the same materials and packaged in an identical way.

The comparative information, combined with the design and intended use comparison with the predicate device, support substantial equivalence to the proposed device Dentsply Sirona Universal Spray Glazes.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.