STEP-I PumEtch is a prophylaxis and phosphoric acid etchant treatment intended for the smface preparation of dentin or enamel prior to tooth restoration, including the application of sealants or for bonding.

Device Description

STEP-1 PumEtch is a tooth preparation formulation combining a 37% phosphoric acid etch and pumice, a polishing agent, into one gel liquid solution. The product is used to prepare natural tooth surfaces for the application of sealants or direct bond appliances.

AI/ML Overview

This describes the acceptance criteria and study proving the device meets them, based on the provided text:

The document is a 510(k) summary for a dental product called STEP-1 PumEtch, which is a prophylaxis and phosphoric acid etchant. The primary method for proving substantial equivalence to predicate devices is through comparative performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Proxy)	Reported Device Performance (Comparative to Predicate)
No statistically significant difference in Shear Bond Strength (SBS)	Demonstrated no statistically significant difference in SBS
No statistically significant difference in pH	Demonstrated no statistically significant difference in pH

Note: The document implies these are the acceptance criteria by stating that the comparative performance testing "demonstrated there is no statistically significant difference between the subject and predicate devices" for these metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the Shear Bond Strength (SBS) and pH comparative performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. The study focuses on direct physical and chemical property comparisons (SBS, pH) rather than expert-based ground truth.

4. Adjudication Method for the Test Set

This is not applicable and not provided. The study design involves direct measurement and comparison of physical/chemical properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. The device is a dental etchant, not an AI or imaging device that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. A standalone algorithm study was not done. The device is a physical/chemical product, not an algorithm.

7. Type of Ground Truth Used

The ground truth or reference for evaluation in this context is the performance of legally marketed predicate devices in terms of Shear Bond Strength and pH. The study aims to show that the new device performs equivalently to these established benchmarks.

8. Sample Size for the Training Set

This is not applicable and not provided. The device is a physical/chemical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable and not provided for the same reasons as above.

Summary

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January 28, 2022

Rounding Third LLC Adrienne Foller Regulatory Consultant ORS Solutions LLC 966 E. 2050 N North Ogden. Utah 84414

Re: K213093

Trade/Device Name: STEP-1 PumEtch Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, EJR Dated: November 29, 2021 Received: December 1, 2021

Dear Adrienne Foller:

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

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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 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,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K213093

Device Name STEP-1 PumEtch

Indications for Use (Describe)

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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Section 5

K213093

510(k) Summary

Name of Sponsor:	Smile Stream, LLC9750 East Easter Avenue, #155Centennial, CO 80112
510(k) Contact:	Adrienne von FollerRegulatory Affairs ConsultantQRS Solutions, LLCTelephone: (801) 916-8188AVonFoller@qrssolutionsllc.com
Date Prepared:	29 November 2021
Submission Type:	Traditional 510(k)
Proprietary Name:	STEP-1 PumEtch
Common Name:	Resin tooth bonding agent
Classification:	21 CFR 872.3200
Device Class:	Class II
Device Product Code:	KLE, EJR
Predicate Device:	Premier Etch
510(k) Applicant:	Premier Dental Company Products
510(k):	K141839
Primary Reference Device:	Enamel Pro
510(k) Applicant:	Premier Dental Company Products
510(k):	K062166
Secondary Reference Device:	DiaEtch
510(k) Applicant:	DiaDent Group International
510(k):	K192273

5.1 Device Description

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5.2 Indications for Use

STEP-1 PumEtch is a prophylaxis and phosphoric acid etchant treatment intended for the surface preparation of dentin or enamel prior to tooth restoration, including the application of sealants or for bonding.

5.3 Basis for Substantial Equivalence:

STEP-1 PumEtch has the same technological characteristics as the predicate device, including:

1. Indications for use
1. Intended use
1. Basic principles of operation
1. Basic formula

The following comparative performance testing was conducted which demonstrated there is no statistically significant difference between the subject and predicate devices.

Shear Bond Strength (SBS)
. pH

The fundamental scientific technology of STEP-1 PumEtch is the same as the previously cleared predicate device. No animal or clinical studies were deemed necessary for a determination of substantial equivalence.

The intended use of the subject device is the same as the predicate device. Based on similarities in indications for use, basic design, and the principle of operation, the STEP-1 PumEtch is substantially equivalent to the previously cleared predicate device.

A primary reference device has been included to support the safety and common use of pumice as a dental prophylaxis. A secondary reference device has been included to support the safety and common use of xanthan gum as a thickening agent in a dental etchant. However, substantial equivalence of the subject device to the reference devices is not required.

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.