(135 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental glaze spray, with no mention of AI or ML technology.
No
The device is used for coating dental restorations made from Sirona CAD/CAM materials, which is an external application for preparing the dental restoration itself, not directly treating a patient's medical condition or disease.
No
The device is a spray used for coating dental restorations to glaze them, which is a manufacturing/finishing process, not a diagnostic one.
No
The device description clearly outlines physical components like an aluminum can, valve, spray nozzle, and glass balls, indicating it is a hardware device containing a glaze material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Glazing of individually designed dental restorations from dental ceramics." This is a process applied to a dental restoration outside of the body.
- Device Description: The device is a spray used to coat dental restorations. It is administered "extra-orally."
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues, to detect diseases or other conditions. This device does not perform any such tests on biological samples.
The device is a dental material used in the fabrication and finishing of dental restorations, which are then placed in vivo (inside the body). However, the device itself is used in vitro (outside the body) during the manufacturing process of the restoration, but it is not an IVD in the regulatory sense.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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 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.
Product components:
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior tooth region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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: Physical state, Granulometry, Appearance (color, transparency), Firing Temperature, Coefficient thermal expansion, Transformation temperature, Bending strength, Chemical solubility, Radioactivity, Cytotoxicity, Thermal Shock Test of Glaze, Chemical Analysis. All these tests passed.
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.
Not Found
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.
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) |
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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 |