Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.

Device Description

Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in a soft gel that does not dry out quickly, that flows through small applicator tips and that washes off readily. Etch-Rite Supreme is colored dark purple for contrast with tooth enamel and easy visualization.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Pulpdent Etch-Rite™ Supreme device.

It's important to note that this document is a 510(k) summary for a dental etchant, which is a medical device, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions related to AI device performance evaluation (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of product and are not present in the document. The evaluation of this device is based on bench testing and substantial equivalence to predicate devices.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Bench Test)	Reported Device Performance
Specific Gravity	1.280
Solubility in Water	100 %
pH	1.0
Appearance and Odor	Dark purple gel with mild, characteristic odor
Shelf-Life	Two years

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

Not applicable. This is a physical dental etchant, not a software device. The "test set" described in the context of AI/SaMD for ground truth and performance validation is not relevant here. The performance testing refers to bench tests on the product itself. The document does not specify the number of samples used for each bench test, but it is implied that standard laboratory practices for material testing were followed.
Data Provenance: The bench testing was conducted by Pulpdent Corporation, presumably at their facilities. No country of origin for data (in the sense of patient data) is relevant here, as it's a material science evaluation.

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

Not applicable. "Ground truth" in the context of clinical expert consensus for imaging or diagnostic algorithms is not relevant for a chemical etchant. The "truth" for the bench tests (e.g., pH value, specific gravity) is determined by objective scientific measurement.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used to establish ground truth from multiple expert opinions, which is not relevant for the bench testing of a chemical product.

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 a physical dental material, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant.

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

Not applicable. This device is a chemical etchant, not an algorithm. Standalone algorithm performance is not a concept applied here.

7. The type of ground truth used:

For the bench tests, the "ground truth" is defined by objective physical and chemical measurements (e.g., specific gravity, pH, solubility, observation of appearance/odor, and stability testing for shelf-life). These are intrinsic properties of the material and are measured directly.

8. The sample size for the training set:

Not applicable. This device is a chemical product, not a machine learning model. The concept of a "training set" for an algorithm that learns patterns from data is not relevant.

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

Not applicable. (As per point 8).

Study Proving the Device Meets Acceptance Criteria

The document describes the "Summary of Performance Testing - Bench" as the study proving the device meets the acceptance criteria.

The study concludes that "Etch Supreme performs as intended" based on the tabulated bench test results. The primary strategy for regulatory approval and demonstrating safety and effectiveness is substantial equivalence to predicate devices, rather than extensive clinical efficacy trials directly for this type of product.

The statement "From the above comparisons, the bench testing, a search of the relevant scientific literature and the organizational experience with the Etch-Rite line of etchants, it can be concluded that Etch-Rite Supreme is substantially equivalent in design, composition, performance and intended use to the predicate products." highlights the approach.

Predicate Devices for Comparison:

Pulpdent Etch-Rite™ 38% Phosphoric Acid Etching Gel (K882576)
Pulpdent Etch Royale™ 37% Phosphoric Acid Etching Gel (K031915)

The comparison table (in section {0}) shows the new device's chemical composition (36% Phosphoric Acid, Silica gel, Propylene glycol), consistency (Soft gel), applicator tip (25 gauge, pre-bent), color (Dark purple), and intended use (Etch dentin, enamel and glass ionomer cements) are substantially equivalent to the predicates, with minor variations (e.g., 36% vs. 38% and 37% phosphoric acid, dark purple vs. blue color) that are deemed not to raise new questions of safety or effectiveness. The bench test results then confirm that these minor compositional differences still result in a product that performs functionally as expected for an etchant.

Summary

{0}------------------------------------------------

MAR 3 0 2012

・

80 Oakland Street Watertown, MA 02472 USA

TEL: 617-926-6666 FAX: 617-926-6262 Pulpdent@pulpdent.com

510(k) Summary

January 17, 2012

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: 617-926-6666 Fax: 617-926-6262 Email: Pulpdent@pulpdent.com

DEVICE NAME:	PULPDENT ETCH-RITE™ SUPREME
CLASSIFICATION NAME:	Resin tooth bonding agent
FDA PRODUCT CODE:	KLE, CFR 872.3200

PULPDENT C

PREDICATE DEVICES: Pulpdent Etch-Rite™ 38% Phosphoric Acid Etching Gel Pulpdent Etch Royale™ 37% Phosphoric Acid Etching Gel

DESCRIPTION:

INTENDED USE

Pulpdent Etch-Rite Supreme is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.

COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent Etch-Rite Supreme is substantially equivalent in design, composition and intended use to the predicate products that have been given 510(k) Premarket approval as Class II Dental Devices under CFR 872.3200.

	PulpdentEtch-Rite Supreme	PulpdentEtch-Rite	PulpdentEtch Royale
		K882576	K031915
ChemicalComposition:	36% Phosphoric AcidSilica gelPropylene glycol	38% Phosphoric AcidSilica gel	37% Phosphoric AcidGlycerinSilica Gel
Consistency	Soft gel	Thixotropic gel	Soft gel
Applicator tip	25 gauge, pre-bent	25 gauge, pre-bent	25 gauge, pre-bent
Color	Dark purple	Blue	Dark blue
Intended Use	Etch dentin, enamel andglass ionomer cements	Etch dentin, enamel andglass ionomer cements	Etch dentin and toothenamel.

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

TEL: 617-926-6666 FAX: 617-926-6262 Pulpdent@pulpdent.com

510(k) Summary

Summary of Performance Testing - Bench

The following test results demonstrate that Etch Supreme performs as intended:

Specific gravity	1.280
Solubility in water	100 %
pH	1.0
Appearance and odor	Dark purple gel with mild, characteristic odor
Shelf-Life	Two years

CONCLUSION:

From the above comparisons, the bench testing, a search of the relevant scientific literature and the organizational experience with the Etch-Rite line of etchants, it can be concluded that Etch-Rite Supreme is substantially equivalent in design, composition, performance and intended use to the predicate products. General usage of Etch-Rite for more than 20 years and Etch Royale for over 10 indicates a high benefit-to-risk ratio.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Mr. Kenneth J. Berk Director of Research Pulpdent Corporation 80 Oakland Street Watertown, MA 02472

MAR 3 0 2012

Re: K120213

Trade/Device Name: Pulpdent Etch-Rite™ Supreme Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: January 17, 2012 Received: January 24, 2012

Dear Mr. Berk:

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. Berk:

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 yours,

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

20213

510(k) Number (if known):

Device Name: Pulpdent Etch-Rite ™ Supreme

Indications For Use:

Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

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

510(k) Number: K062613

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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.