ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH

K080228 · Novamin Technology, Inc. · LBH · Mar 27, 2008 · Dental

Device Facts

• Record ID: K080228
• Device Name: ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
• Applicant: Novamin Technology, Inc.
• Product Code: LBH · Dental
• Decision Date: Mar 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that also provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules.

Device Story

Oralief™ OTC Toothpaste is a fluoride-free, non-aqueous dentifrice containing NovaMin® (calcium sodium phosphosilicate). Designed for daily use by patients to clean teeth and reduce dentin hypersensitivity. Upon contact with an aqueous environment (saliva/water), NovaMin® reacts to form hydroxycarbonate apatite (HCA), which physically occludes exposed dentin tubules, blocking hydrodynamic flow. The device is an over-the-counter product. Clinical benefit includes rapid and continual relief from sensitivity triggers like cold, heat, acids, and sweets.

Clinical Evidence

Bench testing only. In vitro dentin block model demonstrated statistically significant tubule occlusion compared to controls. Radioactive Dentin Abrasion (RDA) testing yielded a mean value of 125.55, below the 250 limit for daily-use safety. Biocompatibility testing performed with no hazardous effects reported.

Technological Characteristics

Non-aqueous toothpaste formulation containing calcium sodium phosphosilicate (NovaMin®). Mechanism: physical occlusion of dentinal tubules via surface reaction forming hydroxycarbonate apatite (HCA). RDA value: 125.55. Fluoride-free.

Indications for Use

Indicated for daily use as a cleaning toothpaste for individuals experiencing tooth sensitivity due to cold, heat, acids, sweets, or contact.

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

• Oralief™ Therapy for Sensitive Teeth (K040858)

Submission Summary (Full Text)

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## 1. SUBMITTER INFORMATION:

MAR 2 7 2008

| Name: | NovaMin Technology, Inc. |
|------------|----------------------------|
| Address: | 13859 Progress Blvd., #600 |
| | Alachua, Florida 32615 USA |
| Phone: | [phone] |
| Facsimile: | [phone] |
| Contact: | Robert G. Rothfritz |

Preparation Date: January 9, 2008

## 2. DEVICE NOMENCLATURE:

| Trade Name: | Oralief™ OTC Toothpaste for Sensitive Teeth |
|----------------------|---------------------------------------------------|
| Common Name: | Dentifrice, Toothpaste |
| Classification Name: | Cavity Varnish (21 CFR 872.3260 Product Code LBH) |

## 3. LEGALLY MARKETED PREDICATE DEVICE:

| Device Name: | Oralief™ Therapy for Sensitive Teeth |
|----------------|--------------------------------------|
| 510(k) Number: | K040858 |
| Applicant: | NovaMin Technology, Inc. |

## 4. DEVICE DESCRIPTION:

Oralief™ OTC Toothpaste for Sensitive Teeth is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® (calcium sodium phosphosilicate) as its active ingredient. The non-aqueous formulation is designed to clean teeth as well as to physically occlude dentin tubules for the reduction of tooth sensitivity. When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

## 5. INTENDED USE:

Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that also provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules.

## 6. TECHNOLOGICAL CHARACTERISTICS:

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The technological characteristics of Oralief™ OTC Toothpaste for Sensitive Teeth are identical to the predicate device Oralief™ Therapy for Sensitive Teeth. Oralief™ OTC Toothpaste for Sensitive Teeth is designed to relieve hypersensitivity associated with exposed dentin by the deposition of a calcium phosphate layer onto the tooth surface that occludes dentinal tubules and blocks hydrodynamic flow.

## 7. SAFETY AND PERFORMANCE DATA:

Many different biocompatibility tests have been performed on NovaMin. The results of these tests indicate that there is no evidence of any hazardous effects to the patient if the product is used as directed.

The tubule occlusion efficacy of Oralief™ OTC Toothpaste for Sensitive Teeth was evaluated using an in vitro dentin block model. The results indicate that Oralief™ OTC Toothpaste for Sensitive Teeth occludes a statistically significant number of tubules when compared to controls.

The relative abrasion level of Oralief™ OTC Toothpaste for Sensitive Teeth was evaluated at Indiana University School of Dentistry. The procedure used was the ADA recommended procedure for determination of toothpaste abrasivity. The result was a mean Radioactive Dentin Abrasion (RDA) value of 125.55. This RDA value is well under the limit considered safe for daily-use (RDA value < 250).

## 8. CONCLUSIONS:

Oralief™ OTC Toothpaste for Sensitive Teeth is considered to be substantially equivalent to the legally marketed predicate device, Oralief™ Therapy for Sensitive Teeth (K040858) because the compositions and actions are identical. The provided tubule occlusion studies, dentin abrasion study. and biocompatibility data demonstrate the safety and efficacy of Oralief™ OTC Toothpaste for Sensitive Teeth as a daily use toothpaste.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 7 2008

Mr. Robert G. Rothfritz Vice President, Operations NovaMin Technology, Incorporated 13859 Progress Boulevard, #600 Alachua, Florida 32615

Re: K080228

Trade/Device Name: Oralief" OTC Toothpaste for Sensitive Teeth Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: January 28, 2008 Received: January 30, 2008

Dear Mr. Rothfritz:

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. Rothfritz

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" (21CFR 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/industry/support/index.html.

Sincerely yours,

Sautte Y. Mckeen Omd

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

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510(k) Number (if known): K0806228

Oralief™ OTC Toothpaste for Sensitive Teeth Device Name:

INDICATIONS FOR USE:

Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules

Prescription Use

OR (Per 21 CFR 801.109) Over-The-Counter Use X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kain Harley for MSR

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

510(k) Number:

SECTION D -STATEMENT OF INDICATIONS FOR USE

Page D-1