BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

K033295 · Novamin Technology, Inc. · LBH · Oct 28, 2003 · Dental

Device Facts

• Record ID: K033295
• Device Name: BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
• Applicant: Novamin Technology, Inc.
• Product Code: LBH · Dental
• Decision Date: Oct 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Butler Nucare® Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare® Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Device Story

Butler Nucare® Root Conditioner with NovaMin® is a two-phase aqueous suspension containing bioactive glass (calcium sodium phosphosilicate). Applied to exposed tooth root dentin by a dental professional; the device reacts with the aqueous environment to physically adhere to dentin and occlude dentinal tubules. The material transforms into hydroxycarbonate apatite (HCA), which is structurally similar to natural tooth mineral. This physical occlusion blocks hydrodynamic flow, reducing tooth hypersensitivity. The device is used in a clinical setting.

Clinical Evidence

Bench testing only. Biocompatibility evaluated via cytotoxicity (ISO 10993-5), intracutaneous irritation, maximization, and acute systemic toxicity. In vitro dentin block model demonstrated statistically significant tubule occlusion compared to positive and negative controls.

Technological Characteristics

Two-phase aqueous suspension of bioactive glass (calcium sodium phosphosilicate: Ca, Na, Si, P, O). Functions via surface reaction to form hydroxycarbonate apatite (HCA). Biocompatible. No software or electronic components.

Indications for Use

Indicated for the rapid relief of hypersensitivity associated with exposed tooth root dentin in patients requiring treatment for dentinal tubule occlusion.

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

• QuelIT™ Desensitizer (K010957)

Submission Summary (Full Text)

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K033295

# OCT 2 8 2003

510(k) Premarket Norification NovaMin Technology, Inc. Butler Nucare® Root Conditioner with NovaMind

### 1. SUBMITTER INFORMATION:

| Name: | NovaMin Technology, Inc. |
|------------|----------------------------|
| Address: | 13709 Progress Blvd., #23 |
| | Alachua, Florida 32615 USA |
| Phone: | [phone] |
| Facsimile: | [phone] |
| Contact: | David C. Greenspan, Ph.D. |
| | |

September 2, 2003 Preparation Date:

#### 2. DEVICE NOMENCLATURE:

| Trade Name: | Butler Nucare ^® Root Conditioner with NovaMin ^® |
|----------------------|-----------------------------------------------------------------------------|
| Common Name: | Inorganic apatite-forming tooth root conditioner and dentin tubule occluder |
| Classification Name: | Cavity Varnish |

### 3. LEGALLY MARKETED PREDICATE DEVICE:

| Device Name: | QuelIT™ Desensitizer |
|----------------|-----------------------|
| 510(k) Number: | K010957 |
| Applicant: | Jeneric/Pentron, Inc. |

### 4. DEVICE DESCRIPTION:

Butler Nucare® Root Conditioner with NovaMin® is a biologically-compatible device designed to condition exposed tooth roots and to physically occlude dentin tubules for the management of sensitive teeth. Butler Nucare Root Conditioner with NovaMin® is an aqueous suspension of an inorganic particulate, NovaMin® (calcium sodium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and 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:

Butler Nucare® Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare® Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

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# 6. TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of Butler Nucare® Root Conditioner with NovaMin® and Quell™ Desensitizer are similar, but not identical. Both devices are designed to relieve hypersensitivity associated with exposed dentin by the deposition of a calcium phosphate layer onto the tooth surface. Both devices are supplied in two phases that are rich in calcium and phosphate ions, which combine to produce a calcium phosphate layer that occludes and blocks hydrodynamic flow. The primary difference between the two devices is that Butler Nucare® Root Conditioner with NovaMin® supplies the calcium and phosphate ions in an aqueous suspension of bioactive glass, whereas Quell™ Desensitizer supplies the ions in an aqueous solution of calcium chloride and potassium phosphate.

## 7. SAFETY AND PERFORMANCE DATA:

The biocompatibility of Butler Nucare Root Conditioner with NovaMin® was evaluated for cytotoxicity (1 - 929), intracutaneous irritation, maximization, and acute systemic toxicity. 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 Butler Nucare Root Conditioner with NovaMin® was evaluated using an in vitro dentin block model. The results indicate that Butler Nucare® Root Conditioner with NovaMin® occludes a statistically significant number of tubules when compared with both positive and negative controls.

### 8. CONCLUSIONS:

Butler Nucare® Root Conditioner with NovaMin® is considered to be substantially equivalent to the legally marketed predicate device, Quell™ Desensitizer (K010957). The provided in vitro performance and biocompatibility data demonstrate the safety and efficacy of Butler Nucare® Root Conditioner with NovaMin for the intended uses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 2003

Mr. David C. Greenspan Responsible Third Party Official NovaMin Technology, Incorporated 13709 Progress Boulevard #23 Alachua, Florida 32615

Re: K033295

Trade/Device Name: Butler Nucare® Root Conditioner with NovaMin® Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: October 13, 2003 Received: October 14, 2003

Dear Mr. Greenspan:

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 vour 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. Greenspan

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/dsma/dsmamain.html

Sincerely vours.

Clips
Elvira Luján, Ph.D.

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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OF INDICATION

510(k) Number (if known): __

Device Name: _ Butler Nucare® Root Conditioner with NovaMin®

INDICATIONS FOR USE:

Butler Nucare® Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare® Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Kein Mulig tax MSP

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K033295

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ___X_

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