Dentsply Sirona Universal Spray Glazes

K202629 · Dentsply Sirona · EIH · Jan 20, 2021 · Dental

Device Facts

• Record ID: K202629
• Device Name: Dentsply Sirona Universal Spray Glazes
• Applicant: Dentsply Sirona
• Product Code: EIH · Dental
• Decision Date: Jan 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Indications for Use

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 Story

Dentsply Sirona Universal Spray Glazes are aerosol-based glazing porcelains for dental restorations (e.g., crowns, bridges). Supplied in ready-to-use spray cans, they are available with or without fluorescing agents to enhance aesthetics. Dental professionals apply a thin, uniform layer to the restoration surface, followed by firing in a dental furnace. A second layer may be applied and fired if necessary. The device simplifies the glazing process by eliminating manual mixing. The organic components and propellant burn off during the firing process, leaving only the ceramic glaze on the restoration. This process improves the surface finish and aesthetic appearance of the dental restoration, benefiting the patient by providing a natural-looking, durable dental prosthesis.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing per ISO 6872:2015 (Dentistry - Ceramic materials) and ISO 10993-5 (in vitro cytotoxicity). Bench testing confirmed compliance with specifications for uniformity, freedom from extraneous material, linear thermal expansion, glass transition temperature, flexural strength (>50 MPa), chemical solubility (<100µg/cm²), and radioactivity (<1 Bq/g U238).

Technological Characteristics

Aerosol spray glazing porcelain containing oxides, organic components, and propellant. Form factor: ready-to-use spray can with cap. Standards: ISO 6872:2015 (Type I Class 1 ceramic materials). Biocompatibility: ISO 10993-5. Shelf life: 3.5 years. Storage: <50°C.

Indications for Use

Indicated for glazing high-strength glass ceramic and zirconia dental restorations in patients requiring dental prostheses.

Regulatory Classification

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.

Predicate Devices

• CEREC SpeedGlaze (K160099)

Reference Devices

• Quattro Porcelain System (K091706)
• Celtra Press (K161269)
• PFZ Porcelain System (K033553)
• Cercon Ceram S (K022796)
• Duceram Plus Ceramic System (K040420)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

- 2. 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: .
- 3. Predicate Device:

| Primary Predicate Device | 510(k) | Company Name |
|--------------------------|---------|-------------------------------|
| CEREC SpeedGlaze | K160099 | Sirona Dental Systems<br>GmbH |

# Reference Devices:

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

| Reference Devices | 510(k) | Company Name |
|--------------------------------|---------|-----------------|
| Quattro Porcelain<br>System | K091706 | Dentsply Sirona |
| Celtra Press | K161269 | Dentsply Sirona |
| PFZ Porcelain System | K033553 | Dentsply Sirona |
| Cercon Ceram S | K022796 | Dentsply Sirona |
| Duceram Plus Ceramic<br>System | K040420 | DeguDent GmbH |

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# 4. Description of Device:

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.

### 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. 1<br>Element | Proposed Device<br>Dentsply Sirona Universal<br>Spray Glazes | Primary Predicate Device<br>CEREC SpeedGlaze | Similarities and Differences |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K202629 | K160099 | N/A |
| Indications for use | Dentsply Sirona Universal Spray<br>Glazes are aerosol glazing<br>porcelains used to glaze high-<br>strength glass ceramic and<br>zirconia dental restorations. The<br>glaze sprays are applied to<br>restorations and fired. | Glazing of individually designed<br>dental restorations from dental<br>ceramics.<br>The CEREC SpeedGlaze Spray<br>is used for coating dental<br>restorations made from Sirona<br>CAD/CAM materials. It is<br>administered extra-orally and is<br>indicated for crowns, inlays,<br>onlays, partial crowns and<br>bridges in the anterior and<br>posterior tooth region. | <span style="white-space: nowrap;">☐ Both the proposed device Dentsply<br/>Sirona Universal Spray Glazes and<br/>predicate device CEREC SpeedGlaze<br/>(K160099) have similar indications for<br/>use and identical intended use as glazing<br/>materials. Both devices are aerosol<br/>sprays designed for glazing dental<br/>restorations.</span><br><span style="white-space: nowrap;">☐ The predicate device CEREC<br/>SpeedGlaze further details the use by<br/>including the types of dental restorations<br/>that can be glazed such as crowns,<br/>inlays, etc. The proposed device<br/>Dentsply Sirona Universal Spray Glazes<br/>have the same use but is worded<br/>differently for simplification purposes.<br/>The proposed Dentsply Sirona Universal<br/>Spray Glazes are marketed to dental<br/>professionals. Types of dental<br/>restorations are covered under ISO<br/>6872:2015 for Type I Class 1 materials.<br/>This is well-known within the dental<br/>industry and does not need to be<br/>explicitly stated within the indications<br/>statement.</span> |
| Table 5. 1 | Proposed Device | Primary Predicate Device | |
| Element | Dentsply Sirona Universal<br>Spray Glazes | CEREC SpeedGlaze | Similarities and Differences |
| 510(k) | K202629 | K160099 | N/A |
| Composition | Major components: oxides<br>Device contains organic<br>components and propellent that is<br>burned-off during the firing<br>process and is not included in the<br>final device. | Major components: oxides<br>Device contains organic<br>components and propellent that is<br>burned-off during the firing<br>process and is not included in the<br>final 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 spraying<br>on to the surface of the dental<br>restorations and a firing process<br>is carried out in a dental furnace. | The glaze is applied by spraying<br>on to the surface of the dental<br>restorations and a firing process<br>is carried out in a dental furnace. | Same. |
| Physical properties | ISO 6872 – Dentistry - Ceramic<br>materials Type 1 Class 1<br>materials | ISO 6872 - Dentistry - Ceramic<br>materials<br>Type 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 with<br>сар. | Packaged in a spray can with<br>сар. | All packaging components are the same. |
| Shelf life / Storage | 3.5 years<br>Avoid exposure to temperatures<br>exceeding 50°C / 122 °F. | 3.5 years<br>Avoid exposure to temperatures<br>exceeding 50°C / 122 °F. | Same. |

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- 7. 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 Test<br>Requirement | Proposed Device<br>Dentsply Sirona | Predicate Device<br>CEREC SpeedGlaze | Specification limit<br>ISO 6872:2015 |
| | Universal Spray<br>Glazes | K160099* | Type I Class 1 |
| Uniformity | Meets criteria | Not reported | Visual inspection |
| Freedom from<br>extraneous material | Meets criteria | Not reported | Visual inspection |
| Linear Thermal<br>Expansion Coefficient,<br>CTE | Meets criteria | $7.5 x 10^{-6} K^{-1} ± 0.5 x$<br>$10^{-6} K^{-1}$ | No specification limit<br>Acceptance criteria is defined<br>as: The coefficient of thermal<br>expansion shall not deviate by<br>more than 0.5 x $10^{-6}K^{-1}$ from the<br>value stated by the<br>manufacturer |
| Glass Transition<br>Temperature | Meets criteria | 490° C ± 10°C | No specification limit<br>Acceptance criteria is defined<br>as: The glass transition<br>temperature shall not deviate by<br>more than 20°C from the value<br>stated by the manufacturer |
| Flexural Strength | Meets criteria<br>>50 MPa | >50 MPa | 50 MPa min. |
| Chemical Solubility | Meets criteria<br><100µg/cm² | <100µg/cm² | < 100µg/cm² min |
| Radioactivity | Meets criteria<br>$<1 Bq/g U^{238}$ | $<1 Bq/g U^{238}$ | $<1 Bq/g U^{238}$ |

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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.