VIVASENS

K030922 · Ivoclar Vivadent, Inc. · LBH · Oct 17, 2003 · Dental

Device Facts

• Record ID: K030922
• Device Name: VIVASENS
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: LBH · Dental
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Vivasens is a film-forming dental varnish applied by dental professionals to treat tooth hypersensitivity. It acts as a protective barrier for exposed dentin. Used in clinical settings following procedures like bleaching, scaling, or root planing, or as a base under restorative materials. The varnish is applied topically to the affected tooth surface to reduce sensitivity and protect dentin. It is not intended for pulp-capping or treatment of sensitivity caused by underlying dental pathology like pulpitis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Film-forming varnish for topical dental application. Class II device (21 CFR 872.3260).

Indications for Use

Indicated for patients with hypersensitive teeth, including hypersensitive cervicals, sensitivity post-bleaching, or sensitivity following professional cleaning, scaling, and root planing. Also indicated for dentin protection under restorative materials. Contraindicated for patients with ingredient allergies, pulpitis, other dental diseases, or for pulp-capping.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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)