(238 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biocompatibility of a topical varnish, with no mention of AI or ML.
Yes
The device is described for the "treatment of hypersensitive teeth," which directly addresses a medical condition (hypersensitivity) and aims to alleviate or cure it. This falls under the definition of a therapeutic device.
No
The device description and intended use indicate it is a treatment for hypersensitive teeth and exposed dentin, not a diagnostic tool for identifying a condition or disease. It is a topically applied varnish, functioning therapeutically.
No
The device description clearly states it is a "topically applied, flavored cavity varnish containing sodium fluoride and calcium phosphate in a rosin based preparation," 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 the treatment of hypersensitive teeth and use on exposed dentin and root sensitivity. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a topically applied varnish that forms a film on tooth surfaces. This is a physical barrier and delivery system for fluoride and calcium phosphate, not a test or assay performed in vitro on biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on safety (biocompatibility) and equivalence to predicate devices with similar therapeutic indications, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Treatment of hypersensitive teeth
- Use on exposed dentin and root sensitivity
- Under temporary restoratives and cements where post-operative sensitivity is of concern
Product codes
LBH
Device Description
Vanish Varnish is a topically applied, flavored cavity varnish containing sodium fluoride and calcium phosphate in a rosin based preparation. The varnish is an insoluble viscous liquid that forms a film on tooth surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin surfaces, tooth 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
3M™ ESPETM Vanish™ Varnish, Enamel Pro® Varnish
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for 3M ESPE. The logo is in black and white, with the "3M" part of the logo being larger than the "ESPE" part. The font is sans-serif and bolded.
Vanish™ Varnish, 5% Sodium Fluoride White Varnish Traditional 510(k)
3M CONFIDENTIAL
ડ. 510(k) Summary
MAR 1 0 2010
3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110
Image /page/0/Picture/8 description: The image shows the logo for 3M ESPE. The logo consists of the text "3M" in a stylized font, followed by the text "ESPE" in a bold, sans-serif font. The text is black and the background is white.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter................................ | 3M Company
3M ESPE Dental Products
3M Center, Bldg. 275-2W-08
St. Paul, MN 55144-1000 USA
Establishment Registration Number:
2110898 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person................................ | Shari L. Myszka
Regulatory Affairs Specialist
Phone: (651) 736-6955
Fax: (651) 736-1599
slmyszka@mmm.com |
| Alternate Contact Person................................ | Gretchen E. Keenan
Regulatory Affairs Manager
Phone: (651) 733-7605
Fax: (651) 736-1599
gekeenan1@mmm.com |
| Date Summary was Prepared......................... | 5 March 2010 |
| Trade Name................................ | Vanish™ Varnish, 5% Sodium
Fluoride White Varnish |
| Common Name(s)................................ | Cavity Varnish |
1
3M ESPE
3M CONFIDENTIAL
11
Vanish™ Varnish, 5% Sodium Fluoride White Varnish Traditional 510(k)
Recommended Classification.......... Cavity Varnish (21 CFR 872.3260)
Predicate Devices: 3M™ ESPETM Vanish™ Varnish Enamel Pro® Varnish
Description and Technology Equivalence:
Vanish™ Varnish, 5% Sodium Fluoride Varnish is classified as Cavity Varnish (21 C.F.R§872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to enamel and dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules.
Vanish Varnish is a topically applied, flavored cavity varnish containing sodium fluoride and calcium phosphate in a rosin based preparation. The varnish is an insoluble viscous liquid that forms a film on tooth surfaces.
The chemical composition is identical, with the exception of tri-calcium phosphate (TCP), to predicate fluoride containing rosin based cavity varnish devices that have been in use for decades. More recently, varnishes have incorporated calcium and phosphate. Published literature indicates that the incorporation of calcium based ingredients into oral care products aid in mineral deposition. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405.
This product is equivalent to current varnishes in properties, intended use and composition. Results provided in the submission confirm the equivalent to the predicate devices with common indications.
Indications for Use:
- · Treatment of hypersensitive teeth
- · Use on exposed dentin and root sensitivity
· Under temporary restoratives and cements where post-operative sensitivity is of concern
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 0 2010
Shari L. Myszka, Ph. D. Regulatory Affairs Specialist 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul. Minnesota 55144
Re: K092141
Trade/Device Name: Vanish™ Varnish, 5% Sodium Fluoride White Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 17, 2010 Received: February 19, 2010
Dear Dr. Myszka:
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.
ul, Minnesota S
3
Page 2- Dr. Myszka
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 yours,
ph 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
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Image /page/4/Picture/1 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text is simple and easy to read.
Vanish™ Varnish, 5% Sodium Fluoride White Varnish Traditional 510(k)
3M CONFIDENTIAL
Indications for Use Statement 4.
Indications for Use
510(k) Number (if known):
Device Name: Vanish™ Varnish, 5% Sodium Fluoride White Varnish
Indications for Use:
· Treatment of hypersensitive teeth
· Use on exposed dentin and root sensitivity
· Under temporary restoratives and cements where post-operative sensitivity is of concern
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
RSBetz DDS for Dr. KPV Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| Page | 1 of 1 |
| 510(k) Number: | K092141 |
March 5, 2010
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