(282 days)
Not Found
No
The device description and performance studies focus on the chemical composition and comparison to existing devices, with no mention of AI or ML.
No.
The device is used for cleaning and polishing the tooth surface prior to procedures like restoration cementation, acid etching for sealants, orthodontic brackets, and composite restorations, but it does not claim to treat or prevent disease.
No
This device is described as a blend of polishing and cleaning agents used for preparation of tooth surfaces, and there is no mention of it being used to diagnose any condition.
No
The device description clearly states it is a "paste form" and contains "polishing and cleaning agents," indicating a physical substance, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for preparing the tooth surface in vivo (within the body) as part of a prophylaxis treatment. It's applied directly to the tooth.
- Device Description: The description details a paste applied to the tooth surface.
- Anatomical Site: The anatomical site is the "tooth surface," which is part of the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health.
IVDs are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely focused on preparing a surface on the body for subsequent dental procedures.
N/A
Intended Use / 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
- o Orthodontic brackets
- o Composite restorations
Product codes (comma separated list FDA assigned to the subject device)
EJR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professionally administered prophylaxis treatment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
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).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
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: 502-634-5357 502-634-4512 FAX: EMAIL: jwaters@whipmix.com
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: 502-634-4512 EMAIL: jwaters@whipmix.com 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)
1
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
Preppies flour of
Pumice | Bisco Cavity
Cleanser | Ultradent
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
Paste is a device specifically
formulated with 2.0% Chlorhexidine
Gluconate. Each cup provides enough
Preppies Plus for a single patient.
Contains no fluoride, oils, or
added flavoring agents. For use on tooth surface prior
to restoration cementation For use prior to acid etching
procedures Sealants Composite
restorations **Minimizes the potential for post-op
sensitivity | Cleans the tooth
surface prior to
acid etching
procedures;
-sealants
-orthodontic
brackets
-composite
restorations
Cleans the tooth
surface prior to
restoration
cementation.
Polishing
amalgam or
composite
restorations. | Used to clean and
moisten tooth
structure | Used for
removal of
residual
temporary
cement prior to
permanent
cementation
and/or for
cleaning debris
while
disinfecting. |
2
| | Prophylaxis of
heavily stained
teeth.
Prepping the
tooth surface
prior to bleaching
procedures. | | |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------|
| Paste solution | Paste solution | Aqueous solution | Slurry |
| Contains 2% (relative to liquid
component) Chlorhexidine Gluconate | Contains no
Chlorhexidine | Contains 2%
Chlorhexidine
Digluconate (CHD) | Contains 2%
(relative to liquid
component)
Chlorhexidine
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.
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
5
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'