· treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion;
· treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
· treatment of tooth hypersensitivity associated with bleaching: and
· treatment of prepared dentin for fillings and/or prosthetic restorations.

Device Description

Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment sites. It is a gel which requires no mixing prior to use and which is applied to treatment sites using a standard applicator brush. Parkell® Desensitizer releases calcium and phosphate ions at the treatment site and stimulates hydroxyapatite formation on the surface of treated dentin and in dentinal tubules. In this manner, the Device hardens following application and forms a layer of mineral hydroxyapatite as well as hydroxyapatite plugs which occlude dentinal tubules, which results in the treatment of dental hypersensitivity.
Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.

AI/ML Overview

This document is a 510(k) Summary for the Parkell® Desensitizer Gel, which is a medical device. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study results that explicitly define and prove acceptance criteria in the format requested.

Therefore, the requested information categories related to acceptance criteria, specific studies proving them, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details are not applicable (N/A) in the context of this 510(k) summary for a desensitizer gel.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance (from "6. Comparison of Technological Characteristics" and "Table 5-A")

The acceptance criteria for the Parkell® Desensitizer Gel are predominantly comparative, demonstrating that its performance is equivalent to or better than the predicate device (Teethmate Desensitizer). The key performance criteria evaluated are:

Acceptance Criteria Category	Specific Criteria	Parkell® Desensitizer Gel Reported Performance	Predicate Device (Teethmate Desensitizer)
Material Form	Equivalent desensitizing function despite different material form.	Gel	Powder/Liquid
Chemical Composition	Water; calcium phosphate-based filler(s)	Water; calcium phosphate-based filler(s)	Water; calcium phosphate-based filler(s)
Surface Coverage	Ability to provide surface coverage of treated dentin.	Yes	Yes
Dentinal Tubule Occlusion	Ability to occlude dentinal tubules.	Yes	Yes
Microshear Bond Strength	Bond strength to dentin of resin-based bonding agents (self-etch mode for agent #1 and #2, total-etch mode for agent #1)	≥15MPa	≥15MPa

The document states that the "technological differences do not raise issues with respect to substantial equivalence and are addressed by comparative performance data provided within this submission." This indicates that the reported performance for Parkell® Desensitizer Gel met or exceeded the performance of the predicate device for these comparative criteria.

The following questions are not applicable or cannot be determined from the provided 510(k) summary, as it describes a non-AI medical device submission based on substantial equivalence, not a study evaluating AI performance with detailed statistical rigor as implied by the questions:

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

N/A. This document describes in vitro (bench) testing, not a clinical "test set" in the context of an AI/algorithm study. The specific sample sizes for the bench tests (e.g., number of samples for microshear bond strength) are not provided. Data provenance is not described for a biological context.

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

N/A. Ground truth in the context of expert consensus is not relevant for this type of device and testing. The "ground truth" for the performance criteria listed (like chemical composition or bond strength) would be established by validated analytical and mechanical testing methods, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods like 2+1 or 3+1 are used for human reader studies, typically in diagnostic imaging or similar fields where interpretation is subjective and consensus is needed. This is not applicable to the bench testing described for a dental desensitizer.

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

N/A. No MRMC study was conducted. This device is a treatment product, not an AI diagnostic tool, and involves no human readers or AI assistance.

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

N/A. Not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the bench data (e.g., chemical composition, surface coverage, dentinal tubule occlusion, microshear bond strength) is established through objective, validated laboratory testing methods following relevant ISO standards and material science principles, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set

N/A. Not an AI algorithm.

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

N/A. Not an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 22, 2019

Parkell, Inc. David Mott Vice President - Legal, R&D, and Regulatory 300 Executive Drive Edgewood, New York 11717

Re: K191103

Trade/Device Name: Parkell Desensitizer Gel Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: Class II Product Code: EJK, LBH Dated: October 24, 2019 Received: October 25, 2019

Dear David Mott:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191103

Device Name Parkell® Desensitizer Gel

Indications for Use (Describe)

Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:

· treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion;
· treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
· treatment of tooth hypersensitivity associated with bleaching: and
· treatment of prepared dentin for fillings and/or prosthetic restorations.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Parkell Inc. The logo is in black and white and features the word "parkell" in a bold, sans-serif font. To the right of "parkell" and slightly below is the word "inc." in a smaller, italicized font. The overall design is simple and professional.

510(k) Summary – K191103

1. Submitter

Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 Phone: 631-389-1545 Fax: 631-389-1546 dmott@parkell.com

Contact Person: David Mott, Vice President - Legal & Regulatory Date of Initial Submission: April 24, 2019 Date of Submission of Final Revision: October 24, 2019

2. Device

Device Proprietary Name:	Parkell® desensitizer
Common or Usual Name:	Tooth desensitizer
Classification Name:	Calcium hydroxide cavity liner
Regulation Number:	21 CFR 872.3250
Product Code:	EJK
Device Classification	II

3. Primary Predicate

Teethmate Desensitizer, K131068, Kuraray Noritake Dental Inc.

4. Device Description

Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.

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Image /page/4/Picture/0 description: The image shows the logo for Parkell Inc. The logo is in black and white and features the word "parkell" in a bold, sans-serif font. To the right of "parkell" and slightly below is the word "inc." in a smaller, italicized font. The logo is simple and professional.

5. Indications for Use

Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:

treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion;
· treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
treatment of tooth hypersensitivity associated with bleaching; and
treatment of prepared dentin for fillings and/or prosthetic restorations.

6. Comparison of Technological Characteristics

Information provided in this 510(k) submission demonstrates that Parkell® Desensitizer Gel is substantially equivalent to the Primary Predicate (Teethmate Desensitizer, K131068), in terms of the intended use and technological characteristics.

Any differences between the Device and the Primary Predicate, for purposes of this 510(k) submission, are of a minor nature as is demonstrated in Table 5-A and throughout this submission. Thus, this submission demonstrates the substantial equivalence between Parkell® desensitizer and the Primary Predicate. A brief comparison of Parkell® Desensitizer Gel to the Primary Predicate is provided below:

Property	Parkell® Desensitizer Gel(Parkell, Inc.)	Primary PredicateTeethmate Desensitizer (K131068, Kuraray Noritake Dental Inc.)
Intended uses	Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments: treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion; treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning; treatment of tooth hypersensitivity associated with bleaching; and treatment of prepared dentin for fillings and/or prosthetic restorations.	Teethmate Desensitizer is indicated for reduction of tooth hypersensitivity by the following treatments: treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion; treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning; treatment of tooth surface before and/or after bleaching; and treatment of prepared dentin for fillings and/or prosthetic restorations.
Classification Product Code	EJK	EJK
Regulation Number	21 CFR 872.3250	21 CFR 872.3250
Principle of operation	tooth desensitizer	tooth desensitizer
Material form	gel	powder/liquid

Table 5-A:

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Image /page/5/Picture/0 description: The image shows the logo for "parkell inc.". The word "parkell" is written in a bold, sans-serif font, with the letters closely spaced together. To the right of "parkell", the word "inc." is written in a smaller, italicized font. The logo is in black and white.

		Parkell® DesensitizerGel(Parkell, Inc.)	Primary PredicateTeethmate Desensitizer(K131068, Kuraray)
Chemical composition		water; calciumphosphate-based filler(s)	water; calciumphosphate-based filler(s)
Surface coverage of treated dentin		yes	yes
Occludes dentinal tubules		yes	yes
Microshear bondstrength to dentin ofresin-based bondingagents followingpretreatment withDevice or PredicateDevice(Pass/fail criteria of atleast about 15MPa)	Commercially-availablebonding agent #1[self-etch mode]	≥15MPa	≥15MPa
	Commercially-availablebonding agent #1[total-etch mode]	≥15MPa	≥15MPa
	Commercially-availablebonding agent #2[self-etch mode]	≥15MPa	≥15MPa

Table 5-A (continued):

As seen above, the differences between the subject and primary predicate devices are limited to materials of construction and material form. These technological differences do not raise issues with respect to substantial equivalence and are addressed by comparative performance data provided within this submission.

7. Biocompatibility and Bench Data

An evaluation of biocompatibility was conducted on Parkell® desensitizer in accordance, e.g., with ISO10993-1:2009, ISO10993-5:2009, ISO10993-10:2010, ISO10993-11:2017, ISO10993-12: 2012, and the FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016). The conclusion of the evaluation is that Parkell® Desensitizer Gel is biocompatible. In addition, an evaluation of the bioactivity of Parkell® desensitizer was performed through analysis of treated dental tissue and via tests performed in accordance with ISO23317:2014.

8. Clinical Performance Data

There was no clinical testing required to support the Device as the intended uses are equivalent to the Predicate Device. These types of devices have been on the market for many years with no reported adverse events. The non-clinical testing detailed in this submission supports the substantial equivalence of the Device.

9. Statement of Substantial Equivalence:

The information provided above supports that Parkell® Desensitizer Gel is substantially equivalent to the Primary Predicate. Although minor differences in design and technology exist between the subject and primary predicate devices, the testing supports that these differences do not raise questions as to the substantial equivalence between the devices. Therefore, it is concluded that Parkell® Desensitizer Gel is substantially equivalent to the Primary Predicate.

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.