WHIP MIX PREPPIES PLUS

K131760 · Whip-Mix Corp. · EJR · Mar 26, 2014 · Dental

Device Facts

• Record ID: K131760
• Device Name: WHIP MIX PREPPIES PLUS
• Applicant: Whip-Mix Corp.
• Product Code: EJR · Dental
• Decision Date: Mar 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1

Intended Use

Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to; . Restoration cementation. . Acid etching procedures: o Sealants o Orthodontic brackets o Composite restorations

Device Story

Preppies Plus is a single-use, flour of pumice paste containing 2% Chlorhexidine Gluconate (CHG). Used by dental professionals in a clinical setting during prophylaxis treatments. Applied to tooth surfaces to clean and prepare the area prior to restoration cementation or acid etching procedures (sealants, orthodontic brackets, composite restorations). The addition of CHG provides a cleaning/disinfecting action while the pumice acts as an abrasive polishing agent. The device is intended to minimize potential post-operative sensitivity. It contains no fluoride, oils, or flavoring agents.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed to evaluate the safety of the 2% Chlorhexidine Gluconate formulation. No clinical data was required or provided.

Technological Characteristics

Paste-form abrasive polishing agent containing 2% Chlorhexidine Gluconate (CHG) and flour of pumice. Single-use cup delivery system. No fluoride, oils, or flavoring agents. Biocompatibility assessed per ISO 14971 risk management standards.

Indications for Use

Indicated for use by dental professionals as part of a prophylaxis treatment on tooth surfaces prior to restoration cementation or acid etching procedures (sealants, orthodontic brackets, composite restorations).

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

• Preppies flour of pumice (510(k) exempt)
• Bisco Cavity Cleanser (K915668)
• Ultradent Consepsis Scrub (K925375)

Submission Summary (Full Text)

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### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

Date Prepared: 05/24/2013

## 1. APPLICANT

Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: [phone] FAX: EMAIL: [e-mail]

#### 2. SUBMITTER and CONTACT

John P. Waters Regulatory Compliance Officer & Official Correspondent for Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

502-634-5357 PHONE: PHONE: FAX: [phone] EMAIL: [e-mail] DATE: 05/24/2013

#### 3. DEVICE NAME

Preppies Plus®

#### 4. COMMON OR USUAL NAME AND CLASSIFICATION

Oral Cavity Abrasive Polishing Agent Regulation Number: 872.6030 Product Code: EJR Classification: Class I

## 5. PREDICATE DEVICE INFORMATION

Preppies flour of pumice (Whip Mix product 510(k) exempt)

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Bisco Cavity Cleanser (K915668) Ultradent Consepsis Scrub (K925375)

## DEVICE DESCRIPTION

Whip Mix Preppies Plus is an innovative blend of polishing and cleaning agents including 2% Chlorhexidine Gluconate (CHG) relative to liquid component and is in a paste form. Each cup provides enough flour of pumice paste for a single use. Preppies Plus has no fluoride, oils, or added flavoring agents.

## 6. INTENDED USE

Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;

- . Restoration cementation.
- . Acid etching procedures:
- o Sealants
- o Orthodontic brackets
- o Composite restorations

## SUBSTANTIAL EQUIVALENCE WITH PREDICATE DEVICES

| (new) Preppies Plus | Whip Mix<br>Preppies flour of<br>Pumice | Bisco Cavity<br>Cleanser | Ultradent<br>Consepsis Scrub |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class I Device | Class I device | Class II device | Class II device |
| 510(k) Pending | 510(k) Exempt | K915668 | K925375 |
| Whip Mix Preppies Plus ® Pumice<br>Paste is a device specifically<br>formulated with 2.0% Chlorhexidine<br>Gluconate. Each cup provides enough<br>Preppies Plus for a single patient.<br>Contains no fluoride, oils, or<br>added flavoring agents. For use on tooth surface prior<br>to restoration cementation For use prior to acid etching<br>procedures Sealants Composite<br>restorations **Minimizes the potential for post-op<br>sensitivity | Cleans the tooth<br>surface prior to<br>acid etching<br>procedures;<br>-sealants<br>-orthodontic<br>brackets<br>-composite<br>restorations<br>Cleans the tooth<br>surface prior to<br>restoration<br>cementation.<br>Polishing<br>amalgam or<br>composite<br>restorations. | Used to clean and<br>moisten tooth<br>structure | Used for<br>removal of<br>residual<br>temporary<br>cement prior to<br>permanent<br>cementation<br>and/or for<br>cleaning debris<br>while<br>disinfecting. |

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| | Prophylaxis of<br>heavily stained<br>teeth.<br>Prepping the<br>tooth surface<br>prior to bleaching<br>procedures. | | |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------|
| Paste solution | Paste solution | Aqueous solution | Slurry |
| Contains 2% (relative to liquid<br>component) Chlorhexidine Gluconate | Contains no<br>Chlorhexidine | Contains 2%<br>Chlorhexidine<br>Digluconate (CHD) | Contains 2%<br>(relative to liquid<br>component)<br>Chlorhexidine<br>Gluconate |

## 7. SAFETY AND EFFECTIVNESS

The use of chlorhexidine in medical device applications have been cleared since the 1970's and is used in many dental applications as well. A thorough search for known risks associated with chlorhexidine in the FDA database was performed. This information was an input to our risk management process. In accordance with ISO 14971 our risk management process has identified the known hazards associated with our new product and all have been mitigated to an acceptable level. Whip Mix's new device, Preppies Plus, is exactly the same as our 510(k) exempt device, Preppies Flour of Pumice except for the addition of 2% Chlorhexidine Gluconate (CHG). Based on the acceptable results of the non-clinical tests for bio-compatibility performed and comparison to the predicates Whip Mix Preppies Plus ® device introduces no new risks and is considered substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three overlapping profiles facing to the right.

Public Health Service

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

#### March 26, 2014

Whip Mix Corporation Mr. John P. Waters Regulatory Compliance Officer & Official Correspondent 361 Farmington Avenue Louisville, KY 40217

Re: K131760

Trade/Device Name: Preppies Plus® Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: December 20, 2013 Received: December 30, 2013

Dear Mr. Waters:

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Waters

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.goy/MedicalDevices/Resources/or You/Industry/default.htm. Also. please note

the regulation cntitled, "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/ReportalProblem/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.

# Mary S. Runner -S

Erin 1. Keith. M.S. Acting Division Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K131760 510(k) NUMBER (IF KNOWN)

DEVICE NAME: PREPPIES PLUS®

#### INDICATIONS FOR USE:

Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;

- . Restoration cementation.
- Acid etching procedures: .
- o Sealants
- Orthodontic brackets o
- 0 Composite restorations

# (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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Sheena A. Green -S 2014.03.26 11:42:34 -04'00'