(18 days)
Not Found
No
The summary describes a dental varnish material and does not mention any AI or ML capabilities.
No
The device description states it is a dental varnish material for glazing surfaces of provisional crowns, bridges, and custom trays, which is a restorative/protective function, not therapeutic.
No
Explanation: The device is a dental varnish material used for glazing surfaces, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "visible light-cured dental, one-component dental varnish material," which is a physical substance, 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 for "glazing the surfaces of provisional crowns, bridges and custom trays." This is a dental application for modifying the surface of a dental restoration or appliance.
- Device Description: It's described as a "visible light-cured dental, one-component dental varnish material." This further reinforces its use as a material applied to dental devices.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for these types of tests.
The information clearly indicates this is a dental material used in the fabrication or finishing of dental devices, not a diagnostic tool.
N/A
Intended Use / Indications for Use
LuxaGlaze is intended for glazing the surfaces of provisional crowns, bridges and custom trays.
Product codes
EBD
Device Description
The LuxaGlaze material is a visible light-cured dental, one-component dental varnish material.
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
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)
No safety or performance testing was required to establish substantial equivalence for LuxaGlaze.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/2 description: The image shows the date August 29, 2001, and the word LuxaGlaze. Below that is a handwritten number, K013179. The number is written in black ink and is slightly slanted to the right. The background of the image is white.
510(k) Summary
| Trade Name: | LuxaGlaze |
|---|---|
| Sponsor: | DMG USA, Inc. |
| 414 South State Street | |
| Dover, DE 19901 | |
| Registration # not yet assigned | |
| Device Generic Name: | Coating material for resin fillings |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II (76EBF). |
The proposed LuxaGlaze material is substantially equivalent to Predicate Devices: currently marketed dental restorative glazing materials such as the belleGlaze material marketed by Kerr Dental Materials, Inc., which was cleared for marketing by FDA in K992067.
Product Description:
The LuxaGlaze material is a visible light-cured dental, one-component dental varnish material.
Indications for Use:
LuxaGlaze is intended for glazing the surfaces of provisional crowns, bridges and custom trays.
Safety and Performance:
Substantial equivalence for this device was based on similarities in materials, design and performance characteristics. No safety or performance testing was required to establish substantial equivalence for LuxaGlaze.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the DMG USA LuxaGlaze material has been shown to be safe and effective for its intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2 2001
Ms. Pamela Papineau DMG USA, Incorporated 414 South State Street Dover, Delaware 19901
Re: K013179
Trade/Device Name: LuxaGlaze Regulation Number: 872.3310 Regulation Name: Dental Varnish Material Regulatory Class: II Product Code: EBD Dated: August 29, 2001 Received: September 24, 2001
Dear Ms. Papineau:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major againations 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.
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Page 2 - Ms. Papineau
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/adrh/dsma/dsmamain.html
Sincerely yours,
Timothy J. Wotowski
Timot 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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August 29, 2001 LuxaGlaze
Page of 1 1 3179
510(k) Number (if known): KQ/3179
Device Name: _LuxaGlaze
Indications for Use:
LuxaGlaze is a light-cure one-bottle varnish for glazing the surfaces of provisional crowns, bridges and custom trays.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
OR
Over-the-Counter Use _______(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 1510(k) Number _
120m