OSSPRAY CLEANING COMPOUND

K062502 · Ospray, Ltd. · EJR · Dec 15, 2006 · Dental

Device Facts

• Record ID: K062502
• Device Name: OSSPRAY CLEANING COMPOUND
• Applicant: Ospray, Ltd.
• Product Code: EJR · Dental
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.

Device Story

OSspray Cleaning Compound is a dry inorganic particulate (calcium sodium phosphosilicate) used in dental prophylaxis. Applied via compressed air system (air polishing) by dental professionals. Upon contact with aqueous environment, particles react to form hydroxycarbonate apatite (HCA), physically adhering to exposed root dentin and occluding dentin tubules. Occlusion blocks hydrodynamic flow, providing relief from tooth sensitivity. Device cleans and polishes tooth surfaces while managing sensitivity.

Clinical Evidence

Bench testing only. Biocompatibility evaluated via cytotoxicity (L-929), intracutaneous irritation, and maximization sensitization tests per ISO 10993. Tubule occlusion efficacy demonstrated using in vitro dentin block model, showing statistically significant occlusion compared to positive and negative controls.

Technological Characteristics

Calcium sodium phosphosilicate (Ca, Na, Si, P, O) bioactive glass powder. Form factor: dry particulate for air polishing. Biocompatibility per ISO 10993. No electronic components or software.

Indications for Use

Indicated for patients undergoing professional dental prophylaxis treatment requiring tooth cleaning, polishing, and relief from tooth sensitivity.

Regulatory Classification

Identification

An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

Predicate Devices

• Prophy Powder (Exempt)
• BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN (K041371)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

### 1. SUBMITTER INFORMATION:

DEC 1 5 2006

OSspray Ltd. Name: Address: 61Thorne Street London SW13 OPT

Phone: [phone] Facsimile: [phone]

Contact: Ian Thompson, Ph.D.

Preparation Date: August 2006

#### 2. DEVICE NOMENCLATURE:

Trade Name: OSspray Cleaning Compound Common Name: Dental Prophylaxis Powder Classification Name: Oral Cavity Abrasive Polishing Agent

#### 3. LEGALLY MARKETED PREDICATE DEVICES:

Device Name: Prophy Powder 510(k) Number: Exempt Applicant: PAC-Dent INTL. Inc (Owner Number 9029860)

Device Name: BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN 510(k) Number: K041371 Applicant: NOVAMIN TECHNOLOGY, INC., 13709 Progress Blvd., Suite. 23, Alachua, FL 32615

#### 4. DEVICE DESCRIPTION:

The OSspray Cleaning Compound is a biocompatible calcium sodium phosphosilicate compound in powder form intended for cleaning and polishing procedures as part of a dental prophylaxis treatment to remove debris from tooth surfaces. The OSspray Cleaning Compound is also intended to physically occlude dentin tubules to provide relief from tooth sensitivity during the prophylaxis treatment. The process of cleaning the tooth surface with the OSspray Cleaning Compound physically occludes dentin tubules for the management of sensitive teeth.

The OSspray Cleaning Compound is a dry inorganic particulate (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, the OSspray Cleaning Compound 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 particles of the compound react to form hydroxycarbonate apatite (HCA), which is chemically similar to natural tooth mineral.

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### 5. INTENDED USE:

The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.

## 6. TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of the OSspray Cleaning Compound and the Prophy Powder are substantially equivalent in that they are both abrasive compounds in powder form designed to polish and clean tooth enamel. The OSspray Cleaning Compound supplies calcium and phosphate ions in the form of a bioactive glass, and the Prophy Powder supplies sodium bicarbonate.

The OSspray Cleaning Compound and the BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN are both composed of bioactive glass particles. Both devices are intended to polish and clean the tooth surface during a prophylaxis treatment. The bioglass component of the Butler predicate device is suspended in glycerin and comes in the form of a paste. The bioglass component of the OSspray Cleaning Compound comes in the form of a dry powder to be applied by a compressed air system (i.e., air polishing). Both devices are also intended for use during a prophylaxis treatment to occlude dentinal tubules and block hydrodynamic flow.

# 7. SAFETY AND PERFORMANCE DATA:

The biocompatibility of the OSspray Cleaning Compound was evaluated by performing cytotoxicity (L-929), intracutaneous irritation, and maximization sensitization tests according to ISO 10993. The results of these tests indicate that this device is biocompatible and safe if used as directed.

The tubule occlusion efficacy of OSspray Cleaning Compound was evaluated using an in vitro dentin block model. The results indicate that the OSspray Cleaning Compound occludes a statistically significant number of tubules when compared with both positive and negative controls.

#### 8. CONCLUSION:

The OSspray Cleaning Compound is substantially equivalent to the Prophy Powder (510(k) exempt) and the BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN (KO41371). The in vitro performance and biocompatibility data demonstrate that the OSspray Cleaning Compound is substantially equivalent to, and as safe and effective as, the legally marketed predicate devices.

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2006

OSspray, Limited C/O Ms. Carmelina G. Allis, Esq Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street NW, Suite 1200 Washington, DC 20005

Re: K062502

Trade/Device Name: OSspray Cleaning Compound Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: December 1, 2006 Received: December 4, 2006

Dear Ms. Allis:

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 - Ms. Allis

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,

Susan Runne
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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SECTION C

# INDICATIONS FOR USE

06 > 502 510(k) Number (if known):

Device Name: OSspray Cleaning Compound

# INDICATIONS FOR USE:

The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 C.F.R. 801 Subpart D) Over-The-Counter Use (21 C.F.R. 801 Subpart C)

Susan Runne

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

062502