(48 days)
Not Found
No
The device description and supporting information focus on the chemical composition and physical properties of a fluoride varnish, with no mention of AI or ML.
Yes
The "Intended Use" section states that the device is used for "relief from tooth surface hypersensitivity," which is a therapeutic effect. Additionally, it is classified as "Cavity Varnish (21 C.F.R§872.3260)" a regulatory classification for therapeutic devices.
No
The document describes a cavity varnish used for providing relief from tooth surface hypersensitivity and forming a film on tooth surfaces, which is a treatment or protective function, not a diagnostic one.
No
The device is a physical substance (varnish) applied to teeth, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for topical application to teeth to relieve sensitivity and protect surfaces. This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it's a "topically applied, flavored cavity varnish" that forms a film on tooth surfaces. This aligns with a therapeutic or protective device, not a diagnostic one.
- Classification: The device is classified as "Cavity Varnish (21 C.F.R§872.3260)". This classification falls under dental devices, not IVD devices.
- Mechanism of Action: The mechanism described is forming a film to occlude compromised surfaces and open dentinal tubules, which is a physical barrier and protective action, not a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
Vanish Varnish is for use on sensitive teeth, over exposed dentin and root surface sensitivity and under temporary restoratives and cements where post-operative sensitivity is of concern.
Product codes
LBH
Device Description
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 in a rosin based preparation. The varnish is an insoluble viscous liguid that forms a film on tooth surfaces. This dispensing system provides simultaneous dispensing of each component for a consistent mix.
The chemical composition is identical to predicate fluoride containing rosin based cavity varnish devices that have in use for decades. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin 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)
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
3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110
090519
Image /page/0/Picture/3 description: The image shows the logo for 3M ESPE. The logo is in black and white and features the text "3M ESPE" in a bold, sans-serif font. The letters are spaced closely together, and the overall design is simple and modern.
APR 1 5 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
Company: Street: ZIP-Code, City: Country: Establishment Registration Number: Official Correspondent:
Phone: Fax: E-mail: Date:
Name of Device
Proprietary Name: Classification Name 3M ESPE Dental Products 3M Center Bldg 260-2A-17 St. Paul, Mn. 55144 USA 2110898 Karen O'Mallev Sr. Regulatory Specialist 651 736-7326 651 737-6049 kdomalley@mmm.com February 20, 2009
Vanish Varnish Cavity Varnish 21 C.F.R. §872.3260 as a Class II device. Cavity Varnish
Common Name:
Predicate Devices
| Device | 510(k) |
|---|---|
| Sci-Pharm DFV Varnish | K982915 |
| Universal Cavity Varnish | K802926 |
| DuraShield Plus | K082198 |
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 in a rosin based preparation. The varnish is an insoluble viscous liguid that forms a film on tooth surfaces. This dispensing system provides simultaneous dispensing of each component for a consistent mix.
The chemical composition is identical to predicate fluoride containing rosin based cavity varnish devices that have been in use for decades. 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:
Vanish Varnish is for use on sensitive teeth, over exposed dentin and root surface sensitivity and under temporary restoratives and cements where post-operative sensitivity is of concern.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen O'Malley, RAC 3M Company Dental Products Division 3M Center, Building 260-2A-17 St. Paul, Minnesota 55144-1000
APR 1 5 2009
Re: K090519
Trade/Device Name: Vanish™M Varnish Regulation Number: 21 CFR 872.3260 Regulatory Class: II Product Code: LBH Dated: March 16, 2009 Received: March 18, 2009
Dear Ms. O'Malley:
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 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.
2
Page 2- Ms. O'Malley
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Torres
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for use
Indications for Use Statement Indications for Use
510(k) Number (if known): K09
Device Name: Vanish™ 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
(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)
Page 1 of 1
Susan Perez
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Y090059