(207 days)
Not Found
None
No
The summary describes a film-like varnish for treating tooth sensitivity and does not mention any AI or ML components.
Yes
The device is intended for the treatment of hypersensitive teeth and various sensitivities, which are therapeutic applications.
No
Vivasens® is a film-like varnish for the treatment of hypersensitive teeth, meaning it is a therapeutic device that treats a condition rather than diagnosing one. Its indications for use are focused on pain relief and protection, not on identifying the cause of sensitivity or any other dental condition. The contraindications also specify that it should not be used if sensitivity arises from pulpitis or other dental disease, reinforcing its role as a treatment rather than a diagnostic tool to determine the underlying cause.
No
The device description clearly states it is a "film-like varnish," which is a physical substance applied to teeth, indicating it is a hardware/material-based device, not software.
Based on the provided information, Vivasens® is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of Vivasens® is for the treatment of hypersensitive teeth by applying a varnish directly to the teeth. It does not involve analyzing samples like blood, urine, or tissue.
- The description focuses on a topical application for treatment. The device description and intended use clearly describe a film-like varnish applied to the teeth for therapeutic purposes.
Therefore, Vivasens® falls under the category of a dental therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Vivasens® is a film-like varnish for the treatment of hypersensitive teeth. Indications include
- treatment of hypersensitive cervicals
- treatment of tooth sensitivities e.g. due to bleaching procedures
- treatment of sensitivities occurring after professional tooth cleaning, scaling and rootplaning procedures
- dentin-protection below restorative materials.
It is Contraindicated if the patient has allergies to any ingredient; If the sensitivity arises from pulpitis or other dental disease; or for Pulp-capping.
Product codes
LBH
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
hypersensitive teeth, hypersensitive cervicals, dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
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.
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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them.
OCT 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna Marie Hartnett Director of QA/ Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K030922
Trade/Device Name: Vivasens Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: July 17, 2003 Received: July 21, 2003
Dear Ms. Hartnett:
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 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.
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Page 2 -Mr. Hartnett
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); 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patucia Cincenteffor
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | Pending K030922 |
|---|---|
| --------------------------- | ----------------- |
Device Name:
VIVASENS
Indications For Use:
Vivasens® is a film-like varnish for the treatment of hypersensitive teeth. Indications include
-
treatment of hypersensitive cervicals
-
treatment of tooth sensitivities e.g. due to bleaching procedures
-
treatment of sensitivities occurring after professional tooth cleaning, scaling and rootplaning procedures
-
dentin-protection below restorative materials.
It is Contraindicated if the patient has allergies to any ingredient; If the sensitivity arises from pulpitis or other dental disease; or for Pulp-capping.
Surer Quares
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K030622
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)