(131 days)
No
The device is a physical glazing material for dental restorations and the summary describes its composition, application, and performance testing based on physical properties and biocompatibility. There is no mention of any software, algorithms, or data processing that would involve AI/ML.
No.
This device is an aerosol glazing porcelain used to glaze dental restorations, not to treat a medical condition or disease.
No
This device is a sprayable glazing porcelain used to glaze dental restorations. Its purpose is to physically modify the surface of dental restorations for aesthetic or protective reasons, not to diagnose a condition or disease.
No
The device is a physical product (aerosol spray glaze) used in dental restorations, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "glaze high-strength glass ceramic and zirconia dental restorations." This is a process performed on a dental restoration outside of the human body.
- Device Description: The description details a "sprayable glazing porcelain" applied to the surface of dental restorations and then fired. This is a material used in the fabrication or finishing of a medical device (the dental restoration), not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Reagents, calibrators, or controls used in a diagnostic test.
The device is a material used in the dental laboratory or clinic setting to finish dental restorations.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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)
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).
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.
No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Dentsply Sirona Universal Spray Glazes.
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.
K091706, K161269, K033553, K022796, K040420
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
§ 872.6660 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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/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
2
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
-
- 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
-
- Device Name:
●
- 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: .
-
- Predicate Device:
| Primary Predicate Device | 510(k) | Company Name |
|---|---|---|
| CEREC SpeedGlaze | K160099 | Sirona Dental Systems |
| GmbH |
Reference Devices:
(Reference devices are included to support the biocompatibility of the proposed devices.)
| Reference Devices | 510(k) | Company Name |
|---|---|---|
| Quattro Porcelain | ||
| System | K091706 | Dentsply Sirona |
| Celtra Press | K161269 | Dentsply Sirona |
| PFZ Porcelain System | K033553 | Dentsply Sirona |
| Cercon Ceram S | K022796 | Dentsply Sirona |
| Duceram Plus Ceramic | ||
| 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
5
| Table 5. 1
Element | Proposed Device
Dentsply Sirona Universal
Spray Glazes | Primary Predicate Device
CEREC SpeedGlaze | Similarities and Differences |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K202629 | K160099 | N/A |
| 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. | Glazing of individually designed
dental restorations from dental
ceramics.
The CEREC SpeedGlaze Spray
is used for coating dental
restorations made from Sirona
CAD/CAM materials. It is
administered extra-orally and is
indicated for crowns, inlays,
onlays, partial crowns and
bridges in the anterior and
posterior tooth region. | ☐ Both the proposed device Dentsply
Sirona Universal Spray Glazes and
predicate device CEREC SpeedGlaze
(K160099) have similar indications for
use and identical intended use as glazing
materials. Both devices are aerosol
sprays designed for glazing dental
restorations.
☐ The predicate device CEREC
SpeedGlaze further details the use by
including the types of dental restorations
that can be glazed such as crowns,
inlays, etc. The proposed device
Dentsply Sirona Universal Spray Glazes
have the same use but is worded
differently for simplification purposes.
The proposed Dentsply Sirona Universal
Spray Glazes are marketed to dental
professionals. Types of dental
restorations are covered under ISO
6872:2015 for Type I Class 1 materials.
This is well-known within the dental
industry and does not need to be
explicitly stated within the indications
statement. |
| Table 5. 1 | Proposed Device | Primary Predicate Device | |
| Element | Dentsply Sirona Universal
Spray Glazes | CEREC SpeedGlaze | Similarities and Differences |
| 510(k) | K202629 | K160099 | N/A |
| Composition | Major components: oxides
Device contains organic
components and propellent that is
burned-off during the firing
process and is not included in the
final device. | Major components: oxides
Device contains organic
components and propellent that is
burned-off during the firing
process and is not included in the
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
on to the surface of the dental
restorations and a firing process
is carried out in a dental furnace. | The glaze is applied by spraying
on to the surface of the dental
restorations and a firing process
is carried out in a dental furnace. | Same. |
| Physical properties | ISO 6872 – Dentistry - Ceramic
materials Type 1 Class 1
materials | ISO 6872 - Dentistry - Ceramic
materials
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
сар. | Packaged in a spray can with
сар. | All packaging components are the same. |
| Shelf life / Storage | 3.5 years
Avoid exposure to temperatures
exceeding 50°C / 122 °F. | 3.5 years
Avoid exposure to temperatures
exceeding 50°C / 122 °F. | Same. |
6
7
-
- Non-Clinical Performance Data
Physical Properties:
- Non-Clinical Performance Data
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 | |||
| Requirement | Proposed Device | ||
| Dentsply Sirona | Predicate Device | ||
| CEREC SpeedGlaze | Specification limit | ||
| ISO 6872:2015 | |||
| Universal Spray | |||
| Glazes | K160099* | Type I Class 1 | |
| Uniformity | Meets criteria | Not reported | Visual inspection |
| Freedom from | |||
| extraneous material | Meets criteria | Not reported | Visual inspection |
| Linear Thermal | |||
| Expansion Coefficient, | |||
| CTE | Meets criteria | $7.5 x 10^{-6} K^{-1} ± 0.5 x$ | |
| $10^{-6} K^{-1}$ | 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 | |||
| Glass Transition | |||
| Temperature | Meets criteria | 490° C ± 10°C | 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 | |||
| Flexural Strength | Meets criteria |
50 MPa | >50 MPa | 50 MPa min. |
| Chemical Solubility | Meets criteria