The ProActive Carem is a premium Prophylaxis Paste with fluoride that gently removes dental plaque and staining. It is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures.

AI/ML Overview

This document is a 510(k) premarket notification for a dental device, specifically a "ProActive Care™ Prophylaxis Paste with Fluoride."

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.

Crucially, a 510(k) submission typically does not include new clinical studies proving device efficacy or meeting specific acceptance criteria in the way a pharmaceutical drug or a high-risk medical device might. Instead, substantial equivalence is often established through non-clinical performance testing, comparisons to predicate devices, and sometimes existing clinical literature.

Therefore, many of the requested items regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of regulatory submission for this specific device.

Based on the provided document, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance:

The document does not specify quantitative acceptance criteria or a study that "proves the device meets the acceptance criteria" in the way one might expect for a novel device undergoing extensive clinical trials. Instead, the device's acceptability is based on its substantial equivalence to predicate devices already on the market.

Substantial Equivalence Determination (Section 8):
The ProActive Care™ Prophylaxis Paste is claimed to be substantially equivalent to the following products:

Nupro® T Prophylaxis Paste with Fluoride and Triclosan (K000169)
ProClude® (K002989)
3M™ Clinpro™ Prophy Paste (K990482)

The implication is that because these predicate devices are considered safe and effective for their intended use, and ProActive Care™ is substantially equivalent, it too is considered safe and effective. The criteria for demonstrating substantial equivalence would primarily involve comparing material composition, intended use, and non-clinical performance (e.g., abrasiveness, fluoride release, stability) to the predicate devices. However, the details of these comparisons are not present in this summary.

Detailed Breakdown of Requested Information:

A table of acceptance criteria and the reported device performance:
- Not Applicable / Not Provided in this document. The document does not contain a table of explicit, quantitative acceptance criteria or reported performance data in the context of a dedicated clinical study for this device. The "performance" is implicitly deemed acceptable by its substantial equivalence to predicate devices.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided in this document. This document does not describe a clinical study with a test set of human subjects or data. The submission relies on demonstrating similarity to existing, approved devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable / Not Provided in this document. There is no "ground truth" establishment in the context of a diagnostic or predictive device. The regulatory body (FDA) reviews the submission and makes a determination of substantial equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided in this document. No test set or adjudication process for diagnostic outcomes is mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable / Not Provided in this document. This device is a prophylaxis paste, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided in this document. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable / Not Provided in this document. No ground truth for diagnostic validation is relevant here. The "ground truth" for the device's acceptability is its demonstrated substantial equivalence to predicate devices based on regulatory review of non-clinical data (e.g., chemical composition, physical properties) and intended use.
The sample size for the training set:
- Not Applicable / Not Provided in this document. This is not a machine learning or AI device that would require a training set.
How the ground truth for the training set was established:
- Not Applicable / Not Provided in this document. Not an AI device.

Summary of what the document does provide:

Device Name: ProActive Care™ Prophylaxis Paste with Fluoride
Intended Use: "To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment." (Page 1 and Page 4)
Classification Name: Oral cavity abrasive polishing agent
Regulatory Class: I
Predicate Devices: Nupro® T Prophylaxis Paste with Fluoride and Triclosan (K000169), ProClude® (K002989), 3M™ Clinpro™ Prophy Paste (K990482) (Page 2)
Decision: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. (Page 3)

Summary

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Ko33785

Proshulax 19

Image /page/0/Picture/1 description: The image shows the logo for Discus Dental Incorporated. The words "DISCUS DENTAL" are in large, bold, sans-serif font, with "DISCUS" in white on a black background and "DENTAL" in black on a white background. Below this, the word "INCORPORATED" is written in a smaller, sans-serif font.

JUN 1 8 2004

II. Summary of Safety and Effectiveness

ProActive Care™ Prophylaxis Paste with Fluoride

1. Date of Summary:
November 20, 2003 Date of Summary 2. Preparation:
Discus Dental, Inc. 3. Applicant:
Vivian Lai, MS Contact Person: 4. Associate, Regulatory Affairs Discus Dental, Inc. 8550 Higuera Street Culver City, CA 90232 310.845.8347 310.845.1537

5. Name of Medical Device:

Proprietary Name:	ProActive Care™ Prophylaxis Paste with Fluoride
Common/Usual Name:	Prophylaxis Paste
Classification Name:	Oral cavity abrasive polishing agent

6. Description of Medical Device

7. Intended Use

The ProActive Carem Prophylaxis Paste with Fluoride is to be used for cleaning and polishing procedures as part of a professionally administrated prophylaxis treatment.

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Image /page/1/Picture/0 description: The image shows the logo for Discus Dental Incorporated. The logo is split into two sections, with the left side being white and the right side being black. The words "DISCUS DENTAL" are written in bold, uppercase letters across the two sections. Below the main text, the word "INCORPORATED" is written in smaller, uppercase letters.

KC3R785

510(k) Notification November 20, 2003 310(K) Notthcation November Paste with Fluoride

Substantial Equivalence Determination 8.

The ProActive Care™ Prophylaxis Paste is substantially equivalent to the following products:

a) Nupro® T Prophylaxis Paste with Fluoride and Triclosan ( K000169)
b) ProClude® (K002989)
c) 3M™ Clinpro™ Prophy Paste (K990482)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2004

Ms. Vivian Lai Associate, Regulatory Affairs Discus Dental, Incorporated 8550 Higuera Street Culver City, California 90232

Re: K033785

Trade/Device Name: ProActive Carem Prophylaxis Paste with Fluoride Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: March 31, 2004 Received: March 5, 2004

Dear Ms. Lai:

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 nnerstate over and on 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 controls provided 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 (1 Nr.), it nay over any addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Ms. Lai

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 modifine Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of any I oderal classes in a suirements, including, but not limited to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF re rur 007), assisted (QS) regulation (21 CFR Part 820); and if requirements as bet form nroduct 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) This letter will and not your finding of substantial equivalence of your device to a premaired 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), if you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 maj obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clus L

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

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Image /page/4/Picture/0 description: The image shows the logo for Discus Dental Incorporated. The words "DISCUS DENTAL" are in bold, uppercase letters on the top line, with "DISCUS" on a white background and "DENTAL" on a black background. Below that, the word "INCORPORATED" is spelled out in uppercase letters.

510(k) Notification November 20, 2003 310(K) Nonzivem Prophylaxis Paste with Fluoride

Indications for Use Statement V.

510 (k) Number: K033785

Device Name: ProActive Care™ Prophylaxis Paste

Indications for Use:

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

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

CONDUCTION – CONTINUE Offer of Davise Firelystion (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR Section 801.109 OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Runn

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, Gental Devices Division of Anesthesions

510(k) Number:

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.