REMESENSE

K082594 · Remedent NV · LBH · Mar 19, 2009 · Dental

Device Facts

• Record ID: K082594
• Device Name: REMESENSE
• Applicant: Remedent NV
• Product Code: LBH · Dental
• Decision Date: Mar 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Remesense is intended for the local management of dental sensitivity by patient application of foam strips impregnated with desensitizing gel.

Device Story

Remesense is a dental desensitizing system consisting of thin, flexible foam strips impregnated with a desensitizing liquid (potassium oxalate) and a tray to hold the strips in place. The device is used for the local management of dental sensitivity. The patient applies the impregnated foam strips to the affected tooth or teeth using the provided tray. The mechanism of action involves the breakdown of potassium oxalate into potassium and oxalic acid; the oxalic acid reacts with calcium ions to form calcium-oxalate crystals, which physically block dentin tubules to alleviate sensitivity. The device is intended for prescription use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and established mode of action (tubule occlusion) common to predicate devices.

Technological Characteristics

Active ingredient: Potassium oxalate. Mechanism: Tubule occlusion via calcium-oxalate crystal formation. Form factor: Tray and impregnated foam strips. Prescription use. Class II device.

Indications for Use

Indicated for use as a tooth desensitizer for patients experiencing dental sensitivity.

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.

Predicate Devices

• UltraEZ (K061438)
• Orajel (K041680)
• SuperSeal (K983477)
• Provident (K073061)

Submission Summary (Full Text)

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# KO82594

### 510(k) Summary

| Submitter Name: | Remedent NV |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | Xavier de Cocklaan 42<br>Deurle, BELGIUM B-9831 |
| Phone Number: | 603 369 3550 |
| Fax Number: | 603 369 3562 |
| Contact Person: | William Greenrose |
| Date Prepared: | 02 September 2008 |
| Device Trade Name: | Remesense |
| Common Name | Tooth Desensitizer |
| Classification Name: | Cavity Varnish |
| Number: | 872.5260 |
| Product Code: | LBH |
| Predicate Devices: | K061438 - UltraEZ, K041680 - Orajel, K983477 - SuperSeal, K073061 -<br>Provident (details in table below) |
| Device Description<br>and Statement of<br>Intended Use | <u>Device Description:</u> Remesense consists of a tray and impregnated<br>foam strips. The Remesense foam strips are thin flexible foam strips,<br>impregnated with a desensitizing liquid. These strips are designed to<br>relieve dental (hyper) sensitivity by patient application to the affected<br>tooth (teeth). The impregnated foam strips are held in place with trays.<br><br><u>Statement of Intended Use:</u> Remesense is intended for the local<br>management of dental sensitivity by patient application of foam strips<br>impregnated with desensitizing gel. |
| Summary of<br>Technological<br>Characteristics | Potassium oxalate breaks down into potassium and oxalic acid. The<br>oxalic acid reacts with calcium ions to form calcium-oxalate crystals.<br>These crystals block the dentin tubules, thereby alleviating dental<br>sensitivity. Blockage of dentin tubules is commonly used by many tooth<br>sensitivity agents to reduce tooth sensitivity, and potassium oxalate is a<br>common material used to block dentin tubules. |

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| Submitter:<br>Remedent | Remesense<br>Premarket Notification: Traditional 510(k) | | K082594 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------|
| Conclusion | The information discussed above demonstrates that the Remesense<br>device is substantially equivalent to the predicate devices | | |
| Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. | | |

- ் This summary does not contain any patient identification information.

| Feature | Remesense | UltraEZ | Orajel | Superseal | Provident |
|------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K061438 | K041680 | K983477 | K073061 |
| Manufacturer | Remedent | Ultradent<br>Products, Inc. | DEL<br>Pharmaceuticals,<br>Inc. | Phoenix Dental,<br>Inc. | Coll Partners, Ltd. |
| Classification # &<br>Product Code | 872.3260<br>LBH | 872.3260<br>LBH | 872.3200<br>KLE | 872.3250<br>EJK | 872.3260<br>LBH |
| Classification<br>Name | Cavity Varnish | Cavity Varnish | Tooth bonding<br>resin agent | Calcium<br>hydroxide cavity<br>liner | Cavity Varnish |
| Common Name | Tooth<br>Desensitizer | Tooth<br>Desensitizer | Tooth<br>Desensitizer | Tooth<br>Desensitizer | Tooth<br>Desensitizer |
| Indications for<br>Use | Tooth<br>Desensitizer | Provides a film<br>like varnish for<br>exposed teeth<br>sealing dentinal<br>tubules of over<br>exposed dentin or<br>other exposed<br>areas where<br>postoperative or<br>other dentin<br>sensitivity is a<br>concern. | Tooth<br>Desensitizer | A potassium<br>oxalate based film<br>forming acid<br>resistant liner and<br>desensitizer that<br>is indicated for<br>application prior<br>to restoration of<br>exposed dentin. | A fluoride<br>containing varnish<br>system intended<br>for use as a<br>desensitizing<br>agent on the<br>surface areas of<br>hypersensitive or<br>potentially<br>sensitive teeth. |
| Mode of Action | Tubule<br>Occlusion | Tubule<br>Occlusion | Tubule<br>Occlusion | Tubule<br>Occlusion | Tubule<br>Occlusion |
| Material<br>Composition | Potassium<br>Oxalate | KNO3 and KF | 2-hydroxyethyl<br>methacrylate | Potassium<br>Oxalate | KF |
| Application | Tray/Kit/Gel | Gel | Liquid w/Swab | Gel | Tray/Kit/Gel |
| Rx/OTC | Rx | Rx | Rx | Rx | Rx |

## Summary of Technical Characteristics

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

MAR 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Remedent NV C/o Mr. William Greenrose President Qserve America, Incorporated 220 River Road Claremont, New Hampshire 03743-5567

Re: K082594

> Trade/Device Name: Remesense Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: March 12, 2009 Received: March 17, 2009

Dear Mr. Greenrose:

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. Greenrose

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Susan Lunnes

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4.1 Indications for Use Statement

510(k) Number (if known):

K082594

Device Name: Remesense

Indications for Use:

Remesense is indicated for use as a tooth desensitizer.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription X Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Sussa Kumar

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082594