(70 days)
Not Found
Not Found
No
The description focuses on the material properties and application of a dental glaze, with no mention of AI or ML.
No.
The device is a dental restorative glaze used to enhance the surface finish of restorations, not to treat or prevent a disease or condition.
No
The device, belleGlaze, is described as a "dental restorative glaze" used to "enhance the surface finish" of existing dental restorations, giving them a "porcelain-like glaze." Its purpose is cosmetic and protective, not to identify or diagnose any disease, condition, or health status.
No
The device description clearly states it is a "resin-based, dental restorative glaze," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enhance the surface finish of dental restorations. This is a direct application to a physical object (the restoration) and not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a condition or provide information about a physiological state.
- Device Description: The device is a dental restorative glaze applied to the surface of a restoration. This aligns with a dental material used for cosmetic or protective purposes, not for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing diagnostic information.
- Using reagents or assays.
The device is clearly intended for use in a dental setting to improve the appearance and potentially the durability of a dental restoration. This falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
belleGlaze is designed to be used to enhance the surface finish of the polished belleGlass restoration. It will impart a porcelain-like glaze on all surfaces, especially on posterior occlusial surfaces.
Product codes
EBD
Device Description
The device is a resin-based, dental restorative glaze which is used to coat belleGlass restorations to give them a porcelain-like, shiny surface, especially on posterior occlusial surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior occlusial surfaces
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Jeneric/Pentron Inc., Sculpture LP Glaze
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
AUG 27 1999
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters that appear to be a combination of letters and numbers. The sequence reads as 'K992067'. The characters are written in a cursive style, with varying stroke thicknesses, and are slightly slanted to the right. The handwriting is clear and legible against the white background.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
June 1999 Date Summary Prepared:
Device Name:
- Trade Name belleGlaze .
- . Common Name - Dental Restorative Glaze
- Classification Name Coating Material for Resin Fillings, per 21 CFR § 872.3310 .
Devices for Which Substantial Equivalence is Claimed:
- Jeneric/Pentron Inc., Sculpture LP Glaze .
Device Description:
The device is a resin-based, dental restorative glaze which is used to coat belleGlass restorations to give them a porcelain-like, shiny surface, especially on posterior occlusial surfaces.
Intended Use of the Device:
The intended use of belleGlaze is to enhance the surface finish of the polished belleGlass restoration. It will impart a porcelain-like glaze on all surfaces, especially on posterior occlusial surfaces.
Substantial Equivalence:
belleGlaze is substantially equivalent to other legally marketed devices in the United States. The dental restorative glaze marketed by Jeneric/Pentron Inc. functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
Image /page/0/Picture/19 description: The image shows a recycling symbol next to the words "Printed on Recycled Paper". The recycling symbol is a universal symbol that indicates that a product is made from recycled materials. The text indicates that the paper is made from recycled materials.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Kerr Dental Materials Center C/O Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re : K992067 belleGlaze Trade Name: Requlatory Class: II Product Code: EBD Dated: June 16, 1999 Received: June 18, 1999
Dear Ms. Boswell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਖੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Boswell
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda,gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section I - Indications for Use
510(k) Number:
Device Name: belleGlaze
Indications for Use:
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belleGlaze is designed to be used to enhance the surface finish of the polished belleGlass restoration. It will impart a porcelain-like glaze on all surfaces, especially on posterior occlusial surfaces.
Suser Roar
(Division Sign-Gri) (Division of Dental, Infection Control, Divisionera! Hospita! Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)