BUTLER CALCI-FLOR PROPHYLAXIS PASTE

K102053 · Sunstar Americas, Inc. · EJR · Feb 3, 2011 · Dental

Device Facts

• Record ID: K102053
• Device Name: BUTLER CALCI-FLOR PROPHYLAXIS PASTE
• Applicant: Sunstar Americas, Inc.
• Product Code: EJR · Dental
• Decision Date: Feb 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1

Intended Use

Butler® Calci-Flor Prophylaxis Paste is designed to clean and polish teeth during professionally administered dental hygiene prophylaxis treatments. Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Device Story

Butler® Calci-Flor Prophylaxis Paste is an abrasive oral polishing agent containing calcium and fluoride; includes humectants, bulking agents, sweetener, flavor, color, and preservatives. Available in various grit levels. Used by dental professionals in a clinical setting during dental prophylaxis treatments. Applied using a prophy angle with a suitable cup. Removes dental stains and polishes teeth. Benefits patient by facilitating professional tooth cleaning and providing fluoride exposure during the procedure.

Clinical Evidence

Bench testing only. Fluoride release data was collected to demonstrate performance equivalence to predicate devices.

Technological Characteristics

Abrasive oral polishing agent containing calcium and fluoride, humectants, bulking agents, sweeteners, flavors, colors, and preservatives. Available in multiple grit levels. Applied via prophy angle and cup. No electronic or software components.

Indications for Use

Indicated for use by dental professionals during professionally administered dental prophylaxis (tooth-cleaning) to remove stain and polish 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

• BUTLER G.U.M. WITH FLUORIDE (K952091)
• SATIN PROPHYLAXIS PASTE (K912945)
• PREMIER DENTAL PRODUCTS CO. (K062166)

Submission Summary (Full Text)

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## (02053

FEB - 3 2011

| Date of Summary | 07/16/2010 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/Contact<br>Person | H. Carl Jenkins |
| | The Wood Burditt Group |
| | 10 E. Scranton Ave., Suite 201 |
| | Lake Bluff, IL 60044 |
| | (ph) [phone] x 205 |
| | (fax) [phone] |
| | (email) [e-mail] |
| | Applicant |
| 4635 W. Foster Ave. | |
| Chicago, IL 60630 | |
| (ph) 773-777-4000 | |
| (fax) 773-777-1417 | |
| Device Name | Butler® Calci-Flor Prophylaxis Paste |
| Common Name | Oral cavity abrasive polishing agent |
| Classification | Oral cavity abrasive polishing agent |
| | Regulation Number: 21 CFR 872.6030 |
| | Product Code: EJR |
| | Panel Code: Dental |
| | Device Class: I |
| Legally Marketed<br>Predicate Devices | BUTLER G.U.M. WITH FLUORIDE |
| | JOHN O. BUTLER CO. |
| | K952091 |
| | ProCode: JES |
| | SATIN PROPHYLAXIS PASTE |
| | DENTSPLY INTL. |
| | K912945 |
| | ProCode: EJR |
| | Device Description |
| PREMIER DENTAL PRODUCTS CO. | |
| K062166 | |
| ProCode: EJR | |
| Butler® Calci-Flor Prophylaxis Paste is an oral cavity abrasive<br>polishing agent that contains calcium and fluoride. This device is | |
| regulated by FDA as a Class I device. | |
| Butler® Calci-Flor Prophylaxis Paste is an abrasive oral | |
| prophylaxis paste (available in one of several levels of grit<br>coarseness), which contains fluoride, calcium, humectants, bulking<br>agents for proper paste formation, a sweetener, flavor, color, and<br>preservatives. This device is intended for use by dental | |
| | professionals, during professionally administered dental<br>prophylaxis treatment (tooth-cleaning), to remove stain from and<br>polish the teeth. Paste application is designed for use with a<br>prophy angle with suitable cup. The device is to be limited to<br>individuals who are professionally trained to perform dental<br>prophylaxis. |
| Intended Use and<br>Indications | Butler® Calci-Flor Prophylaxis Paste is designed to clean and<br>polish teeth during professionally administered dental hygiene<br>prophylaxis treatments. |
| Summary of<br>technological<br>characteristics<br>compared to predicate<br>devices | Butler® Calci-Flor Prophylaxis Paste is made of the same<br>ingredient component materials that are used in lawfully marketed<br>predicate devices, with the same type and durations of patient<br>contact.<br>Butler® Calci-Flor Prophylaxis Paste has the same indications for<br>use and intended use as lawfully marketed predicate devices. |
| Performance Testing /<br>Summary of<br>Substantial<br>Equivalence (SE) | Bench testing was performed on the Butler® Calci-Flor<br>Prophylaxis Paste to ascertain fluoride release data. The results of<br>this testing do not raise new questions of safety and effectiveness,<br>and demonstrates that the device is at least as safe and effective as<br>the legally marketed predicate device. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the border.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Sunstar Americas, Incorporated C/O Mr. Carl Jenkins The Wood Burditt Group 10 E. Scranton Avenue, Suite 201 Lake Bluff, Illinois 60044

FEB - 3 20d

Re: K102053

Trade/Device Name: Butler® Calci-Flor Prophylaxis Paste Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: July 19, 2010 Received: July 22, 2010

Dear Mr. Jenkins:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 899. In addition, FDA may publish further announcements concerning your device in the Federal Register. Comments of the country of the country of the 1

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Page 2- Mr. Jenkins

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Runnes

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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4. Indications for Use Statement

## Indications for Use

510(k) Number (if known): KJO2053

Device Name: Butler® Calci-Flor Prophylaxis Paste

Indications for Use:

Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

510(k) Number: K102053

4. Indications for Use Statement

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