CEREC SpeedGlaze

{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 ( <i>Describe</i> ) | 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) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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. 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 AND FUNCTION б 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: | 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 Spray<br>Glaze (K030859) | CEREC SpeedGlaze<br>(Subject Device,<br>K160099) | Discussion | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>For Use | The Enamelite<br>Porcelains Powders are<br>aerosol devices intended<br>to be used as spray<br>applications of ceramic<br>porcelains and glazes for<br>dental restorations<br>(crowns and bridges),<br>which are produced in<br>dental laboratories. | Glazing of individually<br>designed dental<br>restorations from<br>dental ceramics.<br>The CEREC SpeedGlaze<br>Spray is used for<br>coating dental<br>restorations made from<br>Sirona CAD/CAM<br>materials. It is<br>administered extra-<br>orally and is indicated<br>for crowns, inlays,<br>onlays, partial crowns | Both devices<br>have similar<br>indications for<br>use. The Nova<br>Ceramic spray<br>glaze is indicated<br>to be used with a<br>wider array of<br>crowns and<br>bridges while the<br>CEREC<br>SpeedSpray is<br>indicated to be<br>used with only | {7}------------------------------------------------ | | | and bridges in the<br>anterior and posterior<br>tooth region. | Sirona materials<br>since only these<br>materials have<br>been tested. | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Nova Ceramic Spray<br>Glaze | CEREC SpeedGlaze | NA | | Sponsor | ENAMELITE LLC | Sirona Dental Systems<br>GmbH | NA | | CFR Section | 21 CFR 872.6660 | 21 CFR 872.6660 | Same | | Product<br>Code | EIH | EIH | Same | | Type and<br>Class<br>according to<br>ISO 6872 | NA | Type 1, Class 1A | While the type<br>and class of Nova<br>Ceramic Spray<br>Glaze is<br>unknown, the<br>chemical and<br>physical<br>properties are<br>similar | | Main<br>Chemical<br>Compositions | -Non-CFC propellant<br>(such as isobutane,<br>butane or mixtures)<br>-Glass frit | - Isobutane<br>- Silicate Glass | While the exact<br>percentages of<br>the predicate are<br>unknown, the<br>main<br>composition of<br>both sprays are<br>similar. The Glaze<br>powder,<br>propulsion gas<br>and wetting<br>agents are<br>similar.<br>Differences in<br>organic<br>excipients<br>(solvents,<br>pigments) are not | | | | | | | | | | relevant as they<br>burn without<br>residue | | Physical<br>Properties | Physical state of glass:<br>Powder<br>- CTE of $~10.1 x 10^{-6} x K$<br>-1 (Enamelite<br>AEROpaque) | Physical state of glass:<br>Powder<br>- CTE of $7.5 x 10^{-6} x K^{-1} \pm$<br>$0.5 \cdot 10^{-6} K^{-1}$ | Both devices<br>have similar<br>physical<br>properties and<br>both glazes are in<br>powder form. | | Technology<br>and Main<br>Working<br>Principle | The glaze is applied by<br>spray jet on to the<br>surface of the<br>restorations and a firing<br>process is carried out | The glaze is applied by<br>spray jet on to the<br>surface of the<br>restorations and a firing<br>process is carried out | Same | | Performance<br>Standards | ISO 6872<br>Dentistry - Ceramic<br>materials | ISO 6872<br>Dentistry - Ceramic<br>materials | Same | | Storage | Avoid exposure to<br>temperatures exceeding<br>50 °C/122 °F. | Avoid exposure to<br>temperatures exceeding<br>50 °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<br>(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-<br>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 10993-1:2009<br>Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing<br>Within A Risk Management Process | | ISO 6872 Third Edition Dentistry - Ceramic Materials | | ISO 14971<br>Medical Devices - Application Of Risk Management To Medical Devices | | ISO 15223-1 Second Edition 2012-07-01<br>Medical Devices - Symbols To Be Used With Medical Device Labels, Labeling, And<br>Information To Be Supplied - Part 1: General Requirements | | IEC 62366-1<br>Medical devices - Application of usability engineering to medical devices | | ISO 7405 Second Edition 2008-12-15<br>Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry<br>[Including: Amendment 1 (2013)] | | DIN EN 60721-3-2<br>Classification of environmental conditions - Part 3: Classification of<br>environmental parameters and their severities; Section 2: Transportation (IEC<br>60721-3-2: 1997); German version EN 60721-3-2: 1997 | | ISO 13485:2003 - Medical devices -- Quality management systems --<br>Requirements for regulatory purposes | | ISO 10993-5<br>Biological 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.