The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays.

The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.

Device Description

The Perio Protect Tray is a custom fit tray made from impressions of the patents mouth taken by a licensed dentist. The patient impressions are then sent to a specialized dental laboratory which makes a custom fit tray for the individual patient.

AI/ML Overview

The provided text describes basic performance testing for the Perio Protect Tray, but it does not detail a device that uses AI or advanced analytical methods for diagnosis or decision-making. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert consensus, and comparative effectiveness studies are not applicable to this device.

The "Perio Protect Tray" is a custom-fit dental tray for delivering solutions to gingival crevices. The testing described is functional and safety-related for a physical device, not related to an algorithm's performance.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance for Perio Protect Tray

Category	Acceptance Criteria	Reported Device Performance
Solution Delivery	Demonstrate delivery of solutions to teeth and surrounding tissues, specifically gingival sulcus.	- Method: Sodium Fluorescein dye (mixed with aqueous solution and Peroxyl gel) was applied to the tray. - Procedure: Patients wore trays for 10-15 minutes (morning and evening for one day). - Observation: After 24 hours, black light illumination showed Sodium fluorescein dye was observed in the gingival sulcus. This indicates successful delivery of the solution to the targeted area.
Tray Retention Force	Demonstrate the force necessary to remove the tray.	- Method: A gram gauge was used to remove the tray from the patient's mouth. - Procedure: Each test was repeated 10 times. - Result: An average of the force necessary to remove the tray was computed. (Specific numerical value for the average force is not provided in the summary, only that it was computed).

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in terms of number of patients for either test (solution delivery or retention force). The text uses "The patients wore the trays" and "Trays were also placed in the patient's mouth," suggesting more than one patient, but no specific count.
Data Provenance: Not specified (e.g., country of origin). The study appears to be proprietary testing conducted by the manufacturer or a contracted entity for regulatory submission. It is a prospective test as it describes an experiment being conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This device is a physical dental tray, and the "ground truth" for its performance is directly observable physical phenomena (presence of dye, measured force). There is no "ground truth" established by experts in the context of interpretation or diagnosis as would be relevant for an AI system. The "clinician" determines the choice of solution and usage parameters.

4. Adjudication method for the test set:

None. Adjudication methods (like 2+1, 3+1) are typically used when subjective interpretations or discrepancies in expert opinions need to be resolved, usually for AI-driven diagnostic or screening devices. For the physical tests described, observations (presence of dye) and measurements (force) are direct.

5. 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:

No. This device is not an AI system or an interpretative tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This device is a physical product, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The type of ground truth used:

For Solution Delivery: The "ground truth" was direct observation of a physical phenomenon – the presence of phosphorescent Sodium Fluorescein dye in the gingival sulcus under a black light.
For Tray Retention Force: The "ground truth" was direct measurement using a gram gauge.

8. The sample size for the training set:

Not Applicable. This device does not involve machine learning or AI, so there is no training set in the computational sense. The "custom fit tray" process involves taking impressions of individual patients as part of its manufacturing, but this is not a "training set" for an algorithm.

9. How the ground truth for the training set was established:

Not Applicable. There is no training set for an algorithm.

Summary

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K031809

510(k) Summary

for

Perio Protect Tray

1. DATE PREPARED

January 14, 2004

2. SPONSOR INFORMATION

Main Office

Perio Protect LLC 3929 Bayless Avenue St. Louis, MO 63125

Mailing Address

Perio Protect LLC 3929 Bayless Avenue St. Louis, MO 63125

Contact Person: Duane C. Keller, D.M.D.

(314) 638-4190 (telephone) (314) 638-3900 (facsimile)

Outside Regulatory Counsel

Gray Cary Ware & Freidenrich દામ 1625 Massachusetts Ave., NW - Ste 300 Washington, DC 20036

(202) 238-7749 (telephone) (202) 238-7701 (facsimile)

Contact Person: David L. Rosen, R.Ph., J.D.

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3. DEVICE NAME

Proprietary Name: Perio Protect Tray Common/Usual Name: Dental Tray Classification Name: Disposable Fluoride Tray (per 21 C.F.R § 872.6870 (2002))

4. DEVICE DESCRIPTION AND INTENDED USE

The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.

5. PREDICATE DEVICE

Hoyt Laboratories

Disposable Fluoride Tray - K 811154

Such products are now Class I Exempt per 21 C.F.R § 872.6870 (2002)

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Substantial Equivalence Comparison

	Delivery of Oral Irrigation Materials	Indication for Use	Design	Materials	AnatomicSites
rio Protect TrayFluoride TrayHoyt Laboratories	Site specific	Irrigation / solutions	Custom	Elastomeric	Teeth / gingiva
11154	General area specific	Topical fluoride application	Preformed	Foam	Teeth

6. DEVICE TESTING

PERFORMANCE DATA

A. Data demonstrating different solutions used in the clinician's practice of dentistry are delivered to the teeth and surrounding tissues by use of the Perio Protect Tray.
Sodium Fluorescein dye was mixed in an aqueous solution and applied to the Perio Protect Tray with one drop of Peroxyl (hydrogen peroxide) gel. Sodium Fluorescein is a phosphorescent dye that can be illuminated under a black light.

The patients wore the trays 10 – 15 minutes in the morning and evening for one day. The patients were examined 24 hours later and a black light was used to illuminate the region around the teeth. Sodium fluorescein dye was observed in the gingival sulcus.

B. The force necessary to remove the Perio Protect Tray was also tested.
Trays were also placed in the patient's mouth. A gram gauge was used to remove the tray from the patient's mouth. Each of these tests was repeated 10 times and an average of the force necessary to remove the tray was computed.

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Image /page/3/Picture/0 description: The image shows two drawings of teeth. The top drawing shows a set of teeth labeled 44. The bottom drawing shows a set of teeth labeled 32 and 34.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2004

Perio Protect LLC C/O Dr. David L. Rosen Gray Cary Ware & Freidenrich LLP 1625 Massachusetts Avenue NW, Suite 300 Washington, D.C. 20036-2247

Re: K031809/S1

Trade/Device Name: Perio Protect Tray Regulation Number: 21 CFR 872.6870 Regulation Name: Disposable Flouride Tray Regulatory Class: I Product Code: KMT Dated: October 27, 2003 Received: October 30, 2003

Dear Dr. Rosen:

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.

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 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 - Dr. Rosen

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation 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 Division 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 vours,

Chis

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

Enclosure

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K031809

510(k) Number (if known):

K031809

Device Name:

Indications for Use:

Trade Name: Perio Protect Tray

The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.

PLEASE DO NOT WRITE BELOW THIS LINE (Continue on Another Page If Needed)

Concurrence of CDRH, Office of Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number K031809

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 872.6870 Disposable fluoride tray.

Link to an amendment published at 90 FR 55985, Dec. 4, 2025. (a)
Identification. A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically to the teeth. To use the tray, the patient bites down on the tray which has been filled with a fluoride solution.(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.