PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES

K033449 · Professional Dental Technologies Therapeutics, Inc. · EJR · Jan 7, 2004 · Dental

Device Facts

• Record ID: K033449
• Device Name: PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
• Applicant: Professional Dental Technologies Therapeutics, Inc.
• Product Code: EJR · Dental
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1

Intended Use

The Double-Pro™ Prophylaxis Paste with Fluoride family of devices, manufactured by Professional Dental Technologies Therapeutics, Inc., is intended to be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Device Story

Dental prophylaxis paste; contains fluoride, abrasive, sweetener, water, flavoring, color, thickeners, preservatives. Applied to teeth by dental professionals using prophy angle and rotating rubber cup. Used in clinical settings for cleaning/polishing calculus, stains, and accretions. Fluoride release rate 1.23% (+/- 10%).

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Oral cavity abrasive polishing agent; contains fluoride, abrasive, sweetener, water, flavoring, color, thickeners, preservatives. Available in multiple grit levels. Applied via rotating rubber cup. Class I device.

Indications for Use

Indicated for cleaning and polishing teeth during professionally administered dental prophylaxis treatment by trained dental professionals.

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

• NUPRO® Prophylaxis Paste with Fluoride (K912945)

Submission Summary (Full Text)

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K03349

# 510(k) SUMMARY (21 C.F.R. §§ 807.87(h), 807.92)

## Applicant Information/Address: 1. Professional Dental Technologies Therapeutics, Inc. 500 White Dr. Batesville, Arkansas 72501

- 2. Contact Person/Telephone: Joann Underwood 870-698-3571 (Phone) 870-698-3570 (Fax)
### Date Summary was Prepared 3. October 27, 2003

#### 4. Device's Name:

- A. Proprietary Name: Pro-Dentec's Double-Pro™ Prophylaxis Paste with Fluoride Family of Devices
- B. Common Name: Dental Prophylaxis Paste
- C. Classification Name: Oral Cavity Abrasive Polishing Agent (21 § CFR 872.6030)
- D. Product Code: EJR

#### Legally Marketed Predicate Device: 5.

NUPRO® Prophylaxis Paste with Fluoride made by Dentsply (K912945)

#### Description of the Device 6.

The Double-Pro™ Prophylaxis Paste with Fluoride family of devices, manufactured by Professional Dental Technologies Therapeutics, Inc., are oral cavity abrasive polishing agents that contain fluoride, an abrasive (in one of several available levels of grit courseness), a swectener, water, flavoring, color, thickeners, and preservatives. Double-Pro™ is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to polish and clean calculus, stains, and other accretions from the teeth. Double Pro™ prophy paste is applied to patients' teeth with a prophy angle and rotating rubber cup. Use of Double-ProTM Prophylaxis Paste with Fluoride family of devices is to be limited to individuals who are professional trained to perform dental prophylaxis.

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K033449

#### Statement of Intended Use 7.

The Double-Pro™ Prophylaxis Paste with Fluoride family of devices, manufactured by Professional Dental Technologies Therapeutics, Inc., is intended to be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

#### 8. Summary Comparison Of Devices

Double-Pro 11 Prophylaxis Paste with Fluoride family of devices arc substantially equivalent to the predicate device, NUPRO® Prophylaxis Paste with Fluoride made by Dentsply (K912945). Both contain substantially similar ingredients, including abrasive material, flavor and coloring agents, and releasable fluoride, and are available in several different flavors and grits. Both are intended for use by dental professionals, during professionally administered dental prophylaxis treatment, to clean and polish teeth. Both products are applied directly to the teeth using a handpiecc attachment.

Double-Pro"10 Prophylaxis Paste with Fluoride family of devices has fluoride concentrations that are substantially equivalent to those of NUPRO®. The fluoride release rate for Double-Pro"™ demonstrates the release of 1.23% fluoride (+/- 10%) - identical to the fluoride level of NUPRO®.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2004

Mr. Joann Underwood Attorney Professional Dental Technologies Therapeutics, Incorporated 500 White Drive Batesville, Arkansas 72501

Rc: K033449

Trade/Device Name: Double-Pro™ Prophylaxis Paste with fluoride Family of Devices Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: October 27, 2003 Received: October 29, 2003

Dear Mr. Underwood:

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 prodicate 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 appto tax 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 (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1111), it may of 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. Underwood

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 modi that I DT may Federal statutes and regulations administered by other Federal agencies. of the Act of any I oderal bates and squirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 es reading systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in oduct 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) I mis letter wification. The FDA finding of substantial equivalence of your device to a premarket notified.com - 11 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), n you don't 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 maj overn Small Manufacturers, International and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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K033449

Page 1 of 1

510(k) Number (if known):

Device Name:

Indications For Use:

Double-Pro™ Prophylaxis Paste with Fluoride Family of Devices Family of 'bevrees'
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis_ treatment.

Susan Rurr

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

510(k) Number: K023449

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use | <div style="display:inline-block;"> ✓ </div> |
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| Over-the-Counter Use | |