EtchPro® Etching Gel is a 38% phosphoric acid etching gel in a soft gel form that is used by dental professionals for etching dentin and enamel before tooth restoration.

AI/ML Overview

This document describes the FDA's clearance of the EtchPro® Etching Gel (K200462) as substantially equivalent to a predicate device. The information provided outlines the non-clinical performance data used to demonstrate this equivalence.

Here's an analysis of the provided text in the context of your questions:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format in the way one might expect for a quantitative medical device study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance data presented shows a direct comparison of key attributes between the subject device (EtchPro® Etching Gel) and a predicate/reference device (Acid Etch Gel (Etch-Rite), with Etch-Rite Royale as an additional predicate).

Test Item	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (EtchPro® Etching Gel)
Phosphoric Acid Concentration	Equivalent to predicate (e.g., 38% for reference, 37% for predicate)	Tested (implied to be comparable)
pH	Equivalent to predicate	Tested (implied to be comparable)
Viscosity	Equivalent to predicate (e.g., "soft gel" or similar rheological properties)	Tested (implied to be comparable)
Biocompatibility	Equivalent to predicate (demonstrates no adverse biological reactions)	Demonstrated to be substantially equivalent
Ingredients	Generally similar, with minor differences like excipients (e.g., glycerin)	38% phosphoric acid, Silica, Glycerin, Colorant
Consistency	"Soft gel" (same as predicate device)	Soft gel
Color	"Dark blue" (same as predicate device)	Dark blue
Solubility in water	100% (same as predicate device)	100%

Study Proving Acceptance Criteria:

The study that proves the device meets the "acceptance criteria" (defined as substantial equivalence to predicate devices) is a non-clinical performance study involving side-by-side comparative testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the sample size used for the non-clinical performance tests (phosphoric acid concentration, pH, and viscosity). It only states that "side-by-side performance tests... were conducted."
Data Provenance: The document does not specify the country of origin of the data. It also does not specify whether the data was retrospective or prospective. Given the nature of bench testing, it would generally be considered prospective data collected for the purpose of the 510(k) submission.

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

This question is not applicable to the provided document. The ground truth for this type of non-clinical device (etching gel) is established by objective laboratory measurements of its physical and chemical properties, not by expert consensus or interpretation of images.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical or imaging studies where expert interpretation or consensus is required. For non-clinical bench testing, results are typically determined by direct measurement and analysis according to established laboratory protocols.

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

Not applicable. This is not an AI-powered diagnostic device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithmic device. The device itself (etching gel) is a standalone product.

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

The ground truth for the non-clinical performance tests (phosphoric acid concentration, pH, viscosity, biocompatibility) is established by objective, measurable laboratory standards and comparative data against legally marketed predicate devices. For biocompatibility, this would involve standardized in-vitro or in-vivo tests with defined endpoints, where the "truth" is whether the material elicits a harmful biological response.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, 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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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 & Human Services logo. To the right of that is the FDA logo, which 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.

September 2, 2020

Daisy Ni, Regulatory Affairs Manager Belport Company, Inc., Gingi-Pak 4825 Calle Alto. Camarillo, California 93012

Re: K200462

Trade/Device Name: EtchPro Etching Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: June 1, 2020 Received: June 5, 2020

Dear Daisy Ni:

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 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

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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 (QS) 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 "Nandu" Nandkumar, Ph.D. 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 Statement

510(k) Number : K200462

Device Name: EtchPro® Etching Gel

Indications for Use:

EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.

Type of Use:

Prescription Use ___________ OR Over-The-Counter Use

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K200462 510(k) Summary

Date Prepared:

September 1, 2020

Applicant:

Belport Company, Inc., Gingi-Pak

Address: 4825 Calle Alto, Camarillo, CA 93012

Telephone: (805) 484-1051

Correspondent Contact:

Daisy Ni, Regulatory Affairs Specialist

Telephone: (805) 484-1051 .
Email: dnpacdent@gmail.com

Jiahe Li, Regulatory Affairs Specialist

. Telephone: (805) 484-1051

Device Information:

DEVICE NAME: EtchPro® Etching Gel

TRADE NAME: EtchPro® Etching Gel

COMMON NAME: Tooth etching gel

DEVICE CLASSIFICATION Name: Resin, Tooth Bonding Agent

CLASSIFICATION REGULATION NUMBER: CFR 872.3200 DEVICE CLASSIFICATION: CLASS II CLASSIFICATION PRODUCT CODE: KLE

Predicate Device

	Product Name	Registration No.	Manufacturer
PredicateDevice	Etch-Rite Royale	K031915	Pulpdent Corporation
ReferenceDevice	Acid Etch Gel	K882576	Pulpdent Corporation

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Description of Device

EtchPro® Etching Gel is a 38% phosphoric acid etching gel in a soft gel form that is used by dental professionals for etching dentin and enamel before tooth restoration.

Indications for Use

EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.

Substantial equivalence

A side-by-side comparison table is provided. The similarities among the subject, predicate and reference devices are discussed below.

ItemName	Subject device	PredicateDevice	Reference Device	SubstantialequivalenceAnalysis
Devicename	EtchPro®Etching Gel	Etch- RiteRoyale	Acid Etch Gel(Etch-Rite)	-
Manu-facturer	BelportCompany, Inc.,Gingi-Pak	PulpdentCorporation	PulpdentCorporation
510(K)No.	K200462	K031915	K882576
Classifi-cationName	Resin, ToothBonding Agent	Resin, ToothBonding Agent	Tooth shade resinmaterial.	Same as thepredicate device
Regula-toryClass	Class II	Class II	Class II	Same
ProductCode	KLE	KLE	EBF	Same as thepredicate device
IntendedUse	Etch the dentinor enamel	Etchingdentinor enamel	Etch the dentin,enamel and glassionomer cements	Same as thepredicate device
Descrip-tion ofDevice	EtchPro®Etching Gel is a38% phosphoricacid etching gelin a soft gelform that isused by dentalprofessionalsfor etchingdentin and	Pulpdent Etch-Rite Royale is a37% phosphoricacid etchant ingel form that isusedbythedentalprofessional foretchingdentinorenamel	Etch-Rite EtchingGel is a 38%phosphoric acidetching gel in athixotropic gel formthat is used by thedental professionalfor etching dentinor enamel beforetooth restoration.	Same as thereference devicefor activeingredient andconcentration.Same as thepredicate for thesoft gel form.
	enamel beforetoothrestoration.	before toothrestoration.Etch-RiteRoyale is darkblue for contrastwith toothenamel andeasyvisualization.Etch-RiteRoyale is a softgel that is easilymanipulatedand that rinsescompletelywithout leavingany residue		All devices are fordentalprofessional use.
Ingredient	38%phosphoric acidSilicaGlycerinColorant	37%phosphoric acidSilicaGlycerinColorant	38%phosphoric acidSilicaColorant	Same ingredientsSame as thereference devicefor theconcentration ofactive ingredient(38% phosphoricacid).
Consistency	Soft gel	Soft gel	Thixotropic gel	Same as thepredicate device
Color	Dark blue	Dark blue	Medium blue	Same as thepredicate device
Solubilityin water	100%	100%	100%	Same
Design/Packaging	Pre-filledsyringes withapplicators, in1.2 ml and 30ml	Pre-filledsyringes withapplicators, in1.2 ml, 6ml and25 ml	Pre-filled syringeswith applicators, in1.2 ml and 25 ml	Samepacking/designexcept volumedifferences.
OTC orRx	Rx	Rx	Rx	Same
Sterile	Non-sterile	Non-sterile	Non-sterile	Same
Shelf Life	2 years	2 years	2 years	Same

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The intended use of the EtchPro® Etching Gel is same to that of the predicate device Pulpdent Etch-Rite Etching Gel as they are both indicated to Etch dentin and enamel. EtchPro® Etching, predicate device and reference device share the same ingredients, except EtchPro® Etching

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Gel includes glycerin while Acid Etch Gel (Etch-Rite) does not. Glycerin is a humectant, a FDA recognized generally recognized as safe (GRAS) inactive ingredient.

Non-Clinical performance Data

The side-by-side performance tests with EtchPro® Etching Gel and Acid Etch-Rite) were conducted. The following items were tested: phosphoric acid concentration, pH, and viscosity. The biocompatibility tests were performed and the data showed that EtchPro® Etching Gel is substantial equivalent to Acid Etch Gel (Etch-Rite).

Clinical performance Data

Clinical data was not included in this submission.

Conclusion

Based on the similarities in indications for use and technological characteristics together with results of non-clinical performance testing, we believe that EtchPro® Etching Gel is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.