ZIRCON-F PROPHYLAXIS PASTE

K040988 · Pascal Co., Inc. · EJR · Jul 7, 2004 · Dental

Device Facts

• Record ID: K040988
• Device Name: ZIRCON-F PROPHYLAXIS PASTE
• Applicant: Pascal Co., Inc.
• Product Code: EJR · Dental
• Decision Date: Jul 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Device Story

Zircon-F Prophylaxis Paste is an abrasive polishing agent used by dental professionals during routine dental prophylaxis. The paste is applied to tooth surfaces to remove stains and plaque; it functions via mechanical abrasion. It is intended for use in a clinical dental setting by licensed dental professionals. The device provides a cleaning and polishing effect, aiding in the maintenance of oral hygiene and the removal of extrinsic stains.

Clinical Evidence

No clinical data. Substantial equivalence is based on descriptive information and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Oral cavity abrasive polishing paste. Composition consists of materials substantially equivalent to existing market products. Class I device. No electronic, software, or energy-based components.

Indications for Use

Indicated for use in patients requiring professional dental prophylaxis for cleaning and polishing of teeth.

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

• Double-Pro (K033449)
• Butler Gum Prophy Paste (K024343)
• Nupro Prophylaxis Paste (K000169)

Submission Summary (Full Text)

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JUL - 7 2004

Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and symbols. The sequence starts with what appears to be the letter 'K', followed by the number '0', a symbol resembling the Greek letter 'psi', and then the numbers '0988'. The handwriting style is somewhat cursive, with the numbers and symbols connected in a fluid manner.

Image /page/0/Picture/2 description: The image shows the logo for Pascal Company, Inc. The logo consists of a stylized, rounded "L" shape on the left, followed by the word "Pascal" in a bold, sans-serif font. Underneath "Pascal" is the phrase "Company, Inc." in a smaller font, with a line separating it from the word above. The logo is simple and professional in appearance.

WATS 800/426-805

## IX. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS REQUIRED BY SECTION 807.92C)

| 1) | Submitted by: | Vincent M. Tentarelli |
|----|---------------------------------|--------------------------------------|
| | | Pascal Company, Inc. |
| | | 2929 NE Northup Way |
| | | Bellevue, WA 98004 |
| | | USA |
| 2) | Establishment Registration No.: | 3011632 |
| 3) | Date Prepared: | April 12, 2004 |
| 4) | Device Trade Name: | Zircon-F Prophylaxis Paste |
| 5) | Device Common Name | Prophylaxis Paste |
| 6) | Device Classification Name: | Oral cavity abrasive polishing paste |
| 7) | Device Class: | Class I |

- Substantial equivalence: Zircon-F Prophylaxis Paste is substantially equivalent to the દર) originally classified device described in CFR 872.6030, "Oral cavity abrasive polishing paste." It is also substantially equivalent and nearly identical to (for example ) the following products that are currently on the market, having been cleared by 510(k)s:

| 510(k) Number | Name of Device | Company |
|---------------|-------------------------|----------------------|
| K033449 | Double-Pro | Professional Dental |
| K024343 | Butler Gum Prophy Paste | USBiomaterials Corp. |
| K000169 | Nupro Prophylaxis Paste | Dentsply Intl. |

- 9) The document, "Guidance on the CDRH Premarket Notification Review Program, June 30, 1986 (K86-3)" was used to determine substantial equivalence:
- a) Zircon-F Prophylaxis Paste has the same intended use, for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment, as many cleared by the 510(k) process as shown above.

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- The technological characteristics for this product are the same as those for the b) predicate devices and other paste products currently on the market except for minor variations in the same or similar components.
- Descriptive information provided shows that the materials from which Pascal c) Co., Inc.'s Zircon-F Prophylaxis Paste is made are substantially equivalent (nearly identical with some) to those of similar products, used for identical purposes, currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized symbol of three human figures connected by flowing lines, representing the department's focus on people and their well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2004

Mr. Vincent M. Tentarelli Quality Assurance Manager Pascal Company, Incorporated P.O. Box 1478 Bellevue, Washington 98009-1478

Re: K040988

Trade/Device Name: Zircon-F Prophylaxis Paste Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: April 12, 2004 Received: April 20, 2004

Dear Mr. Tentarelli:

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. Tentarelli

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.

Carls

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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## VII. STATEMENT OF INDICATIONS FOR USE

. ·

841 510 (k) NUMBER (IF KNOWN): J ZIRCON-F PROPHYLAXIS PASTE DEVICE NAME: INDICATIONS FOR USE:

To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Swan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Denta 510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)