(584 days)
Not Found
No
The summary describes a dental varnish for coating resin temporaries and does not mention any AI or ML capabilities.
No.
The device is a dental coating material used to produce a smooth and shiny surface on resin temporaries, not to treat or diagnose a disease or condition.
No
The device is described as a "Varnish for final coating for resin temporaries to produce a smooth and shiny surface" and a "light-curing one-component dental sealing lacquers". Its purpose is to coat dental restorations for aesthetic and protective reasons, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "light-curing one-component dental sealing lacquers" and is applied to dental restorations and cured with a dental light-curing unit. This indicates a physical material and a hardware component (light-curing unit) are involved, not just 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 provide a final coating for resin temporaries to create a smooth and shiny surface. This is a dental restoration process, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a dental sealing lacquer applied to dental restorations and cured with a light. This aligns with a material used in dental procedures, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely related to the physical properties and appearance of dental restorations.
N/A
Intended Use / Indications for Use
Varnish for final coating for resin temporaries to produce a smooth and shiny surface.
Dental sealing lacquer for coating resin temporaries
Product codes (comma separated list FDA assigned to the subject device)
EBD
Device Description
The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The Dreve dental sealing lacquers have been designed, developed, tested and produced according to ISO 13485, CAN/CSA ISO 13485 and European Medical Device Directive 93/42/EEC. The quality system is certified by a Notified Body. Testing has confirmed these devices meet their product specification. A series of in-house tests have been conducted to verify the intended signals are accurate and can maintain performance over its useful life. The new device has been also tested in comparison with the predicate and the main characteristics are the same. An assessment of the biocompatibility according to FDA Recognized Consensus Standard ISO 10993-1 is included in this application. As a result of this assessment/testing we conclude that the device is safe for its intended use and does not raise any new questions compared with the predicate.
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.
K123761 VITA ENAMIC® Glaze
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
§ 872.3310 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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2018
Dreve Dentamid Gmbh Reiner Altmann Head Of Quality Management & Regulatory Affairs Max-Planck-Strasse 31 Unna, Norderhein-Westfalen, 59423 DE
Re: K162408
Trade/Device Name: Nano Varnish, Plaquit, Lightpaint On Surface Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material For Resin Fillings Regulatory Class: Class II Product Code: EBD Dated: February 28, 2018 Received: March 5, 2018
Dear Reiner Altmann:
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.
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 (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.
1
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,
Mary S. Runner -S
forTina Kiang, Ph.D. Acting 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) K162408
Device Name NanoVarnish Plaquit Lightpaint on Surface
Indications for Use (Describe)
Varnish for final coating for resin temporaries to produce a smooth and shinv surface
Type of Use (Select one or both, as applicable
Z 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
Dreve Dentamid
510(k) Summary
| Submitter: | Dreve Dentamid GmbH
Max-Planck-Stra e 31
59423 Unna / Germany |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Reg. No. 1000486347 |
| Contact: | Dr. Reiner Altmann
(Head of Quality Management &
Regulatory Affairs)
Phone: +49-2303-8807-0
E-mail: reiner.altmann@dreve.de |
| Official Correspondent: | Mr. Michael Breer
(Quality Management Representative) |
| Date: | April 4th, 2018 |
| 510(k) number: | K162408 |
| ● Common Name: | Dental sealing lacquer |
| ● Trade/Device Name: | NanoVarnish, Plaquit and Lightpaint on Surface |
| ● Classification Name: | Coating material for resin fillings |
| ● Device Classification: | Class II per 21 CFR 872.3310 |
| ● Product Code: | EBO |
| Primary Predicate Device: | K123761 VITA ENAMIC® Glaze |
Device Description
The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.
Intended Use:
Dental sealing lacquer for coating resin temporaries
Image /page/3/Picture/7 description: The image is a circular logo with the text "TUV NORD" at the top. Below that is the text "TUV NORD-DUTZ GmbH". The bottom of the logo contains the text "ISO 9001 / ISO 13485". The logo is divided into two halves, with the left half being black and the right half being white.
VDDI
Dental Solutions
German Manufact
ve11'an