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.

Device Description

The CEREC SpeedGlaze Spray is used to glaze dental restorations made from the Sirona CAD/CAM materials CEREC Zirconia, inCoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The spray meets the requirements of the ISO 6872:2008 "Dentistry - Ceramic materials". The product consists of a coated aluminum can cap, filled with a glaze and a valve and a spray nozzle, for applying the glaze. The CEREC Speed Glaze Spray is suitable for the coating of dental restorations from the Sirona CAD/CAM materials: CEREC Zirconia, inCoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The CEREC SpeedGlaze spray has to be administered extraorally.

It is indicated for the following parts of dentistry:

crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region.
The product has 8 components as shown below:

Can: Aluminum monobloc spray can
Valve: For releasing the contents when engaged
Can cap PP - Polypropylene, Plastic
Spray nozzle: For spraying onto restoration
14mm Glass balls For mixing of the components before spraying
Glaze Ceramic Silicate glass
Instruction for use Instructions for use document
Folding carton Package

AI/ML Overview

The document describes the CEREC SpeedGlaze, a device used for glazing dental restorations, and its substantial equivalence to a predicate device (Nova Ceramic Spray Glaze). The information provided focuses on non-clinical performance data.

Acceptance Criteria and Device Performance:

Property	Acceptance Criteria (Protocol)	Reported Device Performance/Result
Physical state	Visual inspection	Passed
Granulometry	Laser particle sizer	Passed
Appearance (color, transparency)	Visual inspection	Passed
Firing Temperature	Internal protocol	Passed
Coefficient thermal expansion	ISO EN DIN 6872	Passed
Transformation temperature	ISO EN DIN 6872	Passed
Bending strength	ISO EN DIN 6872	Passed
Chemical solubility	ISO EN DIN 6872	Passed
Radioactivity	ISO EN DIN 6872	Passed
Cytotoxicity	ISO EN DIN 10993-5	Passed
Thermal Shock Test of Glaze	Internal protocol	Passed
Chemical Analysis	DIN 15169	Passed

Study Details:

The provided document describes non-clinical tests rather than a study with a test set of data as one might expect for an AI/device performance evaluation that applies to imaging or diagnostic devices. Instead, it describes laboratory-based performance testing of the physical, chemical, and biological properties of the CEREC SpeedGlaze.

Sample size used for the test set and the data provenance: Not explicitly an "imaging test set" in the traditional sense. The device itself (CEREC SpeedGlaze) and its components were subjected to various laboratory tests. The document does not specify the number of samples or batches tested for each property, nor does it mention data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is based on established ISO and DIN standards for material properties, not expert interpretation of cases. The tests are laboratory-based measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests are objective measurements against defined standards.
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 device is a dental material (glaze), not an AI-assisted diagnostic or imaging system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material testing, not an algorithmic performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or reference for these performance tests are the requirements and methodologies stipulated in international standards such as ISO 6872, ISO 10993-5, and DIN 15169. For example, cytotoxicity is determined by meeting the criteria of ISO 10993-5, and bending strength by ISO 6872.
The sample size for the training set: Not applicable. This device is a material, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2016

Sirona Dental Systems GmbH Mr. Kofi Aninakwa Legal Services Engineer Sirona Dental Systems, Inc. 30-30 47th Avenue, Suite 500 Long Island City, New York 11101

Re: K160099

Trade/Device Name: CEREC SpeedGlaze Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 13, 2016 Received: April 27, 2016

Dear Mr. Aninakwa:

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. 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.

{1}------------------------------------------------

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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160099

Device Name CEREC SpeedGlaze

Indications for Use ( Describe )	Glazing of individually designed dental restorations from dental ceramics.
-----------------------------------------	----------------------------------------------------------------------------

The CEREC Speed Glaze 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

for

Sirona Dental Systems CEREC SpeedGlaze K160099

। SPONSOR

Sirona Dental Systems GmbH Fabrikstrasse 31 64625 Bensheim Germany Contact Person: Kofi Aninakwa Telephone: 718-482-2248

DATE PREPARED 2

3 DEVICE NAME

Proprietary Name	: CEREC SpeedGlaze
Common/Usual Name	: Powder, Porcelain
Classification Name	: Porcelain powder for clinical use
Regulation Number	: 21 CFR 872.6660
ProductCode Device	: E I H
Class	: 2

4 PREDICATE DEVICES

Device Name: NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN K Number: K030859 Manufacturer : ENAMELITE LLC

{4}------------------------------------------------

5 INDICATIONS FOR USE

Glazing of individually designed dental restorations from dental ceramics.

DEVICE DESCRIPTION AND FUNCTION б

It is indicated for the following parts of dentistry:

crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region.
The product has 8 components as shown below:

Component	Remark / Description
1. Can:	Aluminum monobloc spray can
2. Valve:	For releasing the contents when engaged
3. Can cap	PP - Polypropylene, Plastic
4. Spray nozzle:	For spraying onto restoration
5. 14mm Glass balls	For mixing of the components before spraying
6. Glaze Ceramic	Silicate glass
7. Instruction for use	Instructions for use document
8. Folding carton	Package

	Table 1 : Physical Components

{5}------------------------------------------------

The properties including the firing temperature, particle size and solubility are shown below. The components of the CEREC SpeedGlaze can also be found in the subsequent table.

Property	Value
Coefficient of thermal expansion	$7.5 x 10^{-6} x K^{-1} \pm 0.5 \cdot 10^{-6} K^{-1}$
Transformation temperature	490° C ± 10°C
Bending strength	> 50 MPa
Chemical solubility	< 100 µg x cm-2
Granulometry/particle size	D50 = 6µm ± 0.6µm
Cytotoxicity	no cytotoxicity
Radioactivity	< 1 Bq x g-1 U238

PRINCIPLES OF OPERATION 7

The underlying scientific concept is that the glaze is applied by spray jet on to the surface of the ceramic restorations and a firing process is carried out in the chairside oven CEREC SpeedFire. Commercially available chairside ovens like the Vita Vacumat and Ivoclar Programat can also be used.

The product is composed of a can which is coated with epoxyphenol and a spray mechanism including a valve, nozzle and can cap. These allow for the extraoral spraying of the glaze onto the restoration.

The CEREC SpeedGlaze consists mainly of a glaze ceramic, organic excipients and propellant gas. When the valve assembly is engaged, the composition from the container is released and sprayed onto the restoration. During finring, the organic excipients burn without leaving any residue.

The glaze meets the requirements of the ISO 6872:2008 "Dentistry - Ceramic materials".

{6}------------------------------------------------

TECHNOLOGICAL CHARACTERISTICS SUMMARY 8 Comparison to Predicate Device

The CEREC SpeedGlaze is similar to the Nova Ceramic Spray Glaze by Enamelite LLC. The CEREC SpeedGlaze is intended for coating dental restorations. It is made of silicate glass and is applied to dental restorations in an aerosolized form. Similarly, the Nova Ceramic Spray Glaze is intended for glazing dental restorations and is made of glass frit with similar compositions as the CEREC glaze material. It has the same classification name (Porcelain Powder for clinical use) and product code (EIH) as the CEREC SpeedGlaze. Both devices consist of refined aerosol delivery systems used to apply the glaze. They have the same working principle in that the glaze is applied by a spray jet onto the restoration and a firing process is carried out to melt the glaze. The CEREC SpeedGlaze has similar composition to the Nova Ceramic Spray Glaze. Both sprays use non-CFC propellants to eject the contents. Similar wetting agents are also used in both sprays.

Both spravs require firing of the restoration after application of the glaze. The main difference between the CEREC SpeedGlaze and the Nova Ceramic Spray Glaze is the differences in organic excipients (solvents and pigments). However this is not significant as the excipients burn without residue upon firing. Furthermore properties such as bending strength, coefficient of thermal expansion, cytotoxicity, and chemical solubility were tested according to ISO standards ISO 6872 and ISO 7405, and meet the requirements.

	Nova Ceramic SprayGlaze (K030859)	CEREC SpeedGlaze(Subject Device,K160099)	Discussion
IndicationsFor Use	The EnamelitePorcelains Powders areaerosol devices intendedto be used as sprayapplications of ceramicporcelains and glazes fordental restorations(crowns and bridges),which are produced indental laboratories.	Glazing of individuallydesigned dentalrestorations fromdental ceramics.The CEREC SpeedGlazeSpray is used forcoating dentalrestorations made fromSirona CAD/CAMmaterials. It isadministered extra-orally and is indicatedfor crowns, inlays,onlays, partial crowns	Both deviceshave similarindications foruse. The NovaCeramic sprayglaze is indicatedto be used with awider array ofcrowns andbridges while theCERECSpeedSpray isindicated to beused with only

{7}------------------------------------------------

		and bridges in theanterior and posteriortooth region.	Sirona materialssince only thesematerials havebeen tested.
Device Name	Nova Ceramic SprayGlaze	CEREC SpeedGlaze	NA
Sponsor	ENAMELITE LLC	Sirona Dental SystemsGmbH	NA
CFR Section	21 CFR 872.6660	21 CFR 872.6660	Same
ProductCode	EIH	EIH	Same
Type andClassaccording toISO 6872	NA	Type 1, Class 1A	While the typeand class of NovaCeramic SprayGlaze isunknown, thechemical andphysicalproperties aresimilar
MainChemicalCompositions	-Non-CFC propellant(such as isobutane,butane or mixtures)-Glass frit	- Isobutane- Silicate Glass	While the exactpercentages ofthe predicate areunknown, themaincomposition ofboth sprays aresimilar. The Glazepowder,propulsion gasand wettingagents aresimilar.Differences inorganicexcipients(solvents,pigments) are not

			relevant as theyburn withoutresidue
PhysicalProperties	Physical state of glass:Powder- CTE of $~10.1 x 10^{-6} x K$-1 (EnameliteAEROpaque)	Physical state of glass:Powder- CTE of $7.5 x 10^{-6} x K^{-1} \pm$$0.5 \cdot 10^{-6} K^{-1}$	Both deviceshave similarphysicalproperties andboth glazes are inpowder form.
Technologyand MainWorkingPrinciple	The glaze is applied byspray jet on to thesurface of therestorations and a firingprocess is carried out	The glaze is applied byspray jet on to thesurface of therestorations and a firingprocess is carried out	Same
PerformanceStandards	ISO 6872Dentistry - Ceramicmaterials	ISO 6872Dentistry - Ceramicmaterials	Same
Storage	Avoid exposure totemperatures exceeding50 °C/122 °F.	Avoid exposure totemperatures exceeding50 °C/122 °F.	Same

{8}------------------------------------------------

PERFORMANCE DATA 9

Non clinical tests have been performed for CEREC SpeedGlaze to investigate the physical, chemical and biological properties. The CEREC SpeedGlaze consists of a glaze ceramic, propellant gas, pigments and other components and meets the requirements of International Standard ISO 6872 - Dentistry - Ceramic Materials. A critical assessment based on clinical data research along with a risk-benefit-ratio assessing the usability of the intended use was provided to the FDA. Performance Tests were performed to measure the CEREC SpeedGlaze Properties below:

Property	Protocol	Result
Physical state	Visual inspection	passed
Granulometry	Laser particle sizer	passed
Appearance(color, transparency)	Visual inspection	passed

{9}------------------------------------------------

Firing Temperature	Internal protocol	Passed
Coefficient thermal expansion	ISO EN DIN 6872	passed
Transformation temperature	ISO EN DIN 6872	passed
Bending strength	ISO EN DIN 6872	passed
Chemical solubility	ISO EN DIN 6872	passed
Radioactivity	ISO EN DIN 6872	passed
Cytotoxicity	ISO EN DIN 10993-5	passed
Thermal Shock Test of Glaze	Internal protocol	passed
Chemical Analysis	DIN 15169	passed

The CEREC SpeedGlaze also follows the Standards below:

Performance Standards Applied
ISO 10993-1:2009Biological Evaluation Of Medical Devices -- Part 1: Evaluation And TestingWithin A Risk Management Process
ISO 6872 Third Edition Dentistry - Ceramic Materials
ISO 14971Medical Devices - Application Of Risk Management To Medical Devices
ISO 15223-1 Second Edition 2012-07-01Medical Devices - Symbols To Be Used With Medical Device Labels, Labeling, AndInformation To Be Supplied - Part 1: General Requirements
IEC 62366-1Medical devices - Application of usability engineering to medical devices
ISO 7405 Second Edition 2008-12-15Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry[Including: Amendment 1 (2013)]
DIN EN 60721-3-2Classification of environmental conditions - Part 3: Classification ofenvironmental parameters and their severities; Section 2: Transportation (IEC60721-3-2: 1997); German version EN 60721-3-2: 1997
ISO 13485:2003 - Medical devices -- Quality management systems --Requirements for regulatory purposes
ISO 10993-5Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity

{10}------------------------------------------------

CONCLUSION 10

Based on a comparison of indications, composition, principle of operation, features and technical data, the Sirona CEREC SpeedGlaze is substantially equivalent to the predicate device.

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.