(85 days)
No
The description focuses on the chemical composition and physical properties of a fluoride varnish, with no mention of AI or ML.
Yes.
The device is used to treat tooth surfaces by providing a desensitizing action, which falls under the definition of a therapeutic device.
No
This device is a fluoride varnish intended for desensitizing tooth surfaces, not for diagnosing medical conditions.
No
The device description clearly states it is a fluoride varnish, which is a physical substance applied to teeth, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "desensitizing action when applied to tooth surfaces." This is a direct application to the body (in vivo) for a therapeutic or preventative purpose, not for examining specimens derived from the human body (in vitro) to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description reinforces the application to tooth surfaces and its desensitizing action.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
The device is a fluoride varnish applied to teeth, which falls under the category of dental devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MI Varnish is a fluoride varnish with Recaldent™ (CPP-ACP) that has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification.
Product codes (comma separated list FDA assigned to the subject device)
LBH,GBN
Device Description
MI Varnish is a fluoride varnish (5% sodium fluoride with CPP-ACP) which has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification. MI Vamish is packed in unit dose and can be applied on teeth with a disposable brush.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surfaces / teeth
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)
Summary of Physical tests:
| | pH | Consistency
(mm) | Total fluoride
(wt %) |
|----------------|-----|---------------------|--------------------------|
| MI Varnish | 6.6 | 39(2) | 2.4(0.1) |
| Duraflor | 6.8 | 40(1) | 2.2(0.1) |
| Vanish Varnish | 6.4 | 26(1) | 2.6(0.1) |
Summary of Performance Specifications: According to GC Corporation R&D test methods.
As described above, the applicant device, MI Varnish is substantially equivalent to comparative devices, such as Duraflor and Vanish Varnish.
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.
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
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Section 6 - 510(k) Summary
ﻨ
Image /page/0/Picture/1 description: The image shows the alphanumeric string "K102808" in a handwritten style. The characters are bold and slightly slanted, with the "K" being the largest and most distinct character. The numbers are connected, giving the impression of a continuous flow.
Image /page/0/Picture/2 description: The image shows the logo for CCI, which is a company that specializes in ammunition. The logo is black and white and features the letters "CCI" in a bold, sans-serif font. There are two apostrophe-like marks on either side of the letters. The registered trademark symbol is on the bottom right.
DEC 2 2 2010
GC AMERICA IN
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
-
- Submitter Information: GC AMERICA INC.
3737 W. 127ª Street Alsip, IL 60803
Contact Person: Mark Heiss, D.D.S. Phone: (708) 897-4042 Fax: (708) 897-4031
- Submitter Information: GC AMERICA INC.
Alternate Contact: Lori Lappo Phone: (708) 897-4036 Fax: (708) 897-4031
Date Prepared: September 20, 2010
-
- Device Name:
Proprietary Name: MI Varnish Classification Name: Cavity Varnish (21CFR 872.3620) Device Classification: Class II Product Code: гвн
- Device Name:
-
Predicate Devices: 3.
| Company | Device | K Number |
|---|---|---|
| A.R. Medical Inc. | ||
| Pharmascience, Inc. | Duraflor | K961893 |
| 3M ESPE Dental Products | Vanish Varnish, 5% Sodium | |
| Fluoride White Varnish | K092141 | |
| GC Corporation | MI Paste Plus | K070854 |
-
- Device description and Intended Use
MI Varnish is a fluoride varnish (5% sodium fluoride with CPP-ACP) which has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification. MI Vamish is packed in unit dose and can be applied on teeth with a disposable brush.
- Device description and Intended Use
The applicant device, MI Varnish is substantially equivalent to Duraflor and Vanish Varnish in intended use. Both devices are fluoride varnish as Cavity Varnish, and used for desensitizing action when applied to teeth.
Image /page/0/Picture/18 description: The image contains two logos. The logo on the left is a diamond shape with the text "CERTIFIED TO ISO 13485" inside. The logo on the right is a globe with the text "DTA" in the center and the word "MEMBER" above it.
1
The chemical composition is similar to the predicate devices (Duraflor and Vanish Varnish) with the exception of Recaldent (CPP-ACP). Recaldent is found in the predicate device MI Paste Plus.
5. Components and Mode of Action
The applicant device, MI Varnish is a paste formulation delivered in unit dose package and applied on the tooth surfaces with a disposable brush.
The chemical components of MI Varnish are similar to that of Duraflor. Components of MI Varnish that have been used in approved devices, MI Paste Plus (GC Corporation), Cavit G K875133 (3M ESPE Dental products)/Vanish Varnish, K092141 (3M ESPE Dental products) are listed in the chemical formulation.
The mode of action of the applicant device is substantially equivalent to that of the predicate devices, Duraflor and Vanish Varnish.
6. Technological characteristics:
MI Varnish contains two new components that have not been used in dental varnish or predicate devices.
Hydrogenated rosin is a rosin derivative. It is made with hydrogenation treatment of usual rosin (CAS No. 8050-09-7). Rosin (Colophony) and other rosin derivatives are used as adhesive agents in FDA approved dental varnishes. These include Duraflor, Vanish Varnish, Enamel Pro Varnish, K062683 (Premier), and the other fluoride varnishes.
Rosin and hydrogenated rosin are structurally similar. Hydrogenated rosin retains the basic structure of rosin and has extra conjugated double bonds. The difference is reflected in appearance, color and physicochemical properties between rosin and derivatives, but not on toxicological properties.
Diethylene glycol monoethyl ether is a solvent of polyvinyl acetate. The compound is already being used in Japan as medical device in "Caviton EX" for temporary filling material. (The number: 221AABZX00131000 is approved by Health and Welfare Ministry in Japan)
7. Summary of Physical tests:
| | pH | Consistency
(mm) | Total fluoride
(wt %) |
|----------------|-----|---------------------|--------------------------|
| MI Varnish | 6.6 | 39(2) | 2.4(0.1) |
| Duraflor | 6.8 | 40(1) | 2.2(0.1) |
| Vanish Varnish | 6.4 | 26(1) | 2.6(0.1) |
Summary of Performance Specifications
According to GC Corporation R&D test methods.
As described above, the applicant device, MI Varnish is substantially equivalent to comparative devices, such as Duraflor and Vanish Varnish.
2
- Description of Safety and Substantial Equivalence: 8.
The applicant device is substantially equivalent to the predicate devices in its intended use.
Most of the chemical components in MI Varnish have been used in the predicate devices. MI Varnish contains two new components, however, one is a rosin derivative and another one is already being used as medical device in Japan. So, we believe that this fact well supports the compatibility of MI Varnish, and the safety of the applicant device is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mark Heiss, DDS Director -Academic and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
DEC 2 2 2010
Re: K102808 Trade/Device Name: MI Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: September 27, 2010 Received: September 28, 2010
Dear Dr. Heiss:
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.
4
Page 2 – Dr. Heiss
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
hh for.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
K10 2808 510(k) Number (if known): Device Name: MI Varnish
DEC 2 2 2010
Indications for Use:
MI Varnish is a fluoride varnish with Recaldent™ (CPP-ACP) that has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quarrer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102808
i '