PREVENTECH Prophylaxis Paste with Fluoride is intended to be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

Device Description

PREVENTECH Prophylaxis Paste with Fluoride is an oral cavity abrasive polishing agent containing sodium fluoride in a blend of enamel polishing and cleaning abrasive agents in a paste form designed for professional application to the teeth during the course of standard dental hygiene procedures. PREVENTECH Prophylaxis Paste with Fluoride is sweetened with Xylitol and offered in various grit levels and various flavors.

The standard mode of application for PREVENTECH Prophylaxis Paste with Fluoride is by use of a low speed Dental Handpiece and accessories, (21 § CFR 872.4200) and a Prophylaxis Cup, (21§ CFR 872.6290).

AI/ML Overview

The provided text is for a 510(k) summary for a prophylaxis paste, not a complex medical device with AI or software components requiring a detailed study of its performance against acceptance criteria in the way described in the prompt. Therefore, much of the requested information, such as sample size for test sets, expert-established ground truth, MRMC studies, or standalone algorithm performance, is not applicable or available in this document.

However, I can extract the relevant information from the document regarding the device's performance criterion and the study used to establish substantial equivalence.

Acceptance Criteria and Device Performance for PREVENTECH Prophylaxis Paste with Fluoride

The primary performance criterion for the PREVENTECH Prophylaxis Paste with Fluoride to establish substantial equivalence was its Relative Enamel Abrasion (REA). The predicate device's REA performance served as the acceptance criterion that the proposed device needed to meet.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Predicate Device Performance)	Reported Device Performance (PREVENTECH Prophylaxis Paste with Fluoride)	Study Reference
Similar REA performance to ENAMEL PRO Professional Prophylaxis Paste with ACP (K062166)	Demonstrates similar performance for enamel abrasion. (Identified as Prophy Paste C)	Final Report, Relative Enamel Abrasion (REA) Study, REA09-284

2. Sample Size and Data Provenance for the Test Set

Sample Size Used for the Test Set: Not specified in the provided summary.
Data Provenance: The study "Relative Enamel Abrasion (REA) Study, REA09-284" was conducted. The country of origin of the data is not specified in the summary. The study appears to be laboratory-based rather than involving human subjects (retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

This is not applicable as the test evaluates a physical property (enamel abrasion) of a dental paste, not the interpretation of medical images or data by experts. The ground truth would be established through standardized laboratory testing protocols for REA.

4. Adjudication Method

Not applicable for this type of laboratory performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of medical images/data, which is not the case for a prophylaxis paste.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a dental paste, not an algorithm. The REA study is a standalone performance study of the paste itself.

7. Type of Ground Truth Used

The ground truth for the REA study would be established through a standardized laboratory measurement of enamel abrasion, likely using a validated in-vitro method.

8. Sample Size for the Training Set

Not applicable. This is a physical product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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K100539

510(k) SUMMARY

(21 C.F.R.§ 807.87(a), 807.92)

JUN 1 7 2010

Applicants Information/Address: 1. Preventive Technologies, Inc 4330 Matthews-Indian Trail Road Indian Trail, North Carolina 28079
1. Establishment Registration Number: 1061053
1. Contact Person/Telephone: Kenneth S. Peterson 704-849-2416 (Phone) 704-849-2417 (Fax)
1. Date Summary was Prepared: February 18, 2010

ડ. Device Identification:

A. Panel: DENTAL
B. Proprietary Name: PREVENTECH Prophylaxis Paste with Fluoride
C. Common Name: Dental Prophylaxis Paste
D. Classification Name: Oral Cavity Abrasive Polishing Agent (215 CFR 872.6030)
E. Classification: Class I
F. Product Code: EJR

Legally Marketed Predicate Device(s): 6.

ENAMEL PRO™ Professional Prophylaxis Paste with ACP (Amorphous A. Calcium Phosphate), Premier Dental (K062166)
B. NUPRO® (Satin) Prophylaxis Paste with Fluoride, Dentsply International,

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(K912945)

Proposed Labeling Sufficient to Describe the Device, Its Intended Use, and the Directions for Its Use: (807.87(e)), (continued);

7. Description of the Device:

PREVENTECH Prophylaxis Paste with Fluoride is an oral cavity abrasive polishing agent containing sodium fluoride in a blend of enamel polishing and cleaning abrasive agents in a paste form designed for professional application to the teeth during the course of standard dental hygiene procedures. PREVENTECH Prophylaxis Paste with Fluoride is sweetened with Xylitol® and offered in various grit levels and various flavors.

8. Statement of Intended Use:

PREVENTECH Prophylaxis Paste with Fluoride is intended to be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. (218 CFR 872.6030),

9. Technological Characteristics and Comparison of Devices

A. The technological characteristics of the Proposed device. PREVENTECH Prophylaxis Paste with Fluoride is substantially equivalent to the Predicate devices, ENAMEL PRO Professional Prophylaxis Paste with ACP. (K062166) and NUPRO (Satin) Prophylaxis Paste with Fluoride, (K912945) in:
- i.) Intended Use: The Proposed device, PREVENTECH Prophylaxis Paste with Fluoride and Predicate devices, ENAMEL PRO Professional Prophylaxis Paste with ACP, (K062166) and NUPRO (Satin) Prophylaxis Paste with Fluoride, (K912945) have the same Intended Use;
  - For cleaning and polishing procedures as part of a professionally ટ્વ. administered prophylaxis treatment (218 872.6030).
- ii.) Composition: The Proposed device, PREVENTECH Prophylaxis Paste with Fluoride and Predicate devices. ENAMEL PRO Professional Prophylaxis Paste with ACP, (K062166) and NUPRO (Satin) Prophylaxis Paste with Fluoride, (K912945) are similar in components used;
  - Sodium fluoride, 1.23% Fluoride ion, a.
  - Pumice as the abrasive agents at various grit levels for cleaning. b. polishing, stain and plaque removal,
  - c. Glycerin and/or other humectants polyols for moisture control. viscosity and lubrication during use,
  - d. Xylitol® or sodium saccharin as sweetening agents,

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Flavoring and color agents. e.
Proposed Labeling Sufficient to Describe the Device, Its Intended Use, and the Directions for Its Use: (807.87(e)), (continued);
iii.) Shelflife/Expiration Dating: The Proposed device, PREVENTECH Prophylaxis Paste with Fluoride will be labeled with an expiration date of two (2) years from date of manufacture. This statements is similar to the Predicate devices, ENAMEL PRO Professional Prophylaxis Paste with ACP, (K062166) and NUPRO (Satin) Prophylaxis Paste with Fluoride, (K912945).
iv.) Method of application; Prophylaxis Paste is applied to teeth during a routine dental hygiene procedure via the use of a low speed Dental Handpiece and accessories, (21§ 872.4200) and a Prophylaxis Cup, 218872.6290) at RPM of less than 5000.
Primary Package; The Proposed device, PREVENTECH Prophylaxis Paste v.) with Fluoride and Predicate devices, ENAMEL PRO Professional Prophylaxis Paste with ACP. (K062166) and NUPRO (Satin) Prophylaxis Paste with Fluoride, (K912945) are packaged into 2 gram Individual Use cups,
vi.) Relative Enamel Abrasion (REA); The Proposed device, PREVENTECH Prophylaxis Paste with Fluoride and Predicate device, ENAMEL PRO Professional Prophylaxis Paste with ACP, (K062166) demonstrate similar performance for enamel abrasion. The Proposed device, PREVENTECH Prophylaxis Paste with Fluoride is identified as Prophy Paste C and Predicate device, ENAMEL PRO Professional Prophylaxis Paste with ACP, (K062166) is identified as Prophy Paste B as referenced in Final Report, Relative Enamel Abrasion (REA) Study, REA09-284.

10. Substantial Equivalence (SE) Summary Statement

In summary, we believe the Proposed device, PREVENTECH Prophylaxis Paste with Fluoride is substantially equivalent in composition and performance to the Predicate devices ENAMEL PRO Professional Prophylaxis Paste with ACP, (K062166) and NUPRO (Satin) Prophylaxis Paste with Fluoride, (K912945) as referenced in this submission. The components used in the Proposed device, PREVENTECH Prophylaxis Paste with Fluoride are similar to those components used in the Predicate devices described within this submission as well as other dental prophylaxis products.

CONFIDENTIAL

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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 & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Mr. Kenneth S. Peterson Vice President, Research and Development Preventitive Technologies, Incorporated 4330 Mathews-Indian Trail Road Indian Trail, North Carolina 28079

JUN 1 7 2010

Re: K100539

Trade/Device Name: PREVENTECH Prophylaxis Paste with Flouride Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: 1 Product Code: EJR Dated: May 27, 2010 Received: June 4, 2010

Dear Mr. Peterson:

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. Peterson

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

for

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

Enclosure

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INDICATIONS FOR USE STATEMENT

(21 CFR §§ 807.87(h), 807.92) .

510(K) Number (if known):

Device Name: PREVENTECH Prophylaxis Paste with Fluoride.

Indications for Use:

For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly for MSN

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

510(k) Number: K100539

Regulation Number and Section

§ 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.