(126 days)
No
The device description and performance studies focus on the chemical and physical properties of the etching solution, with no mention of AI or ML.
No
The device is described as a "prophylaxis and phosphoric acid etchant treatment" used for "surface preparation of dentin or enamel prior to tooth restoration" and for "bonding." It is not described as treating a disease or condition, which is characteristic of a therapeutic device.
No
Explanation: The device is a "prophylaxis and phosphoric acid etchant treatment" used for "surface preparation" of teeth prior to restoration or bonding. Its function is to prepare the tooth surface, not to diagnose a condition or disease.
No
The device description clearly states it is a "gel liquid solution" and a "tooth preparation formulation," indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surface preparation of dentin or enamel prior to tooth restoration, including the application of sealants or for bonding. This is a direct treatment applied to the tooth surface, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "tooth preparation formulation" applied to the tooth surface.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition. It's a preparatory step for a restorative procedure.
IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device is applied directly to the patient's tooth.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KLE, EJR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin or enamel (tooth surfaces)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
No animal or clinical studies were deemed necessary for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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)
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.
| 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
510(k) Summary
| Name of Sponsor: | Smile Stream, LLC
9750 East Easter Avenue, #155
Centennial, CO 80112 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Adrienne von Foller
Regulatory Affairs Consultant
QRS Solutions, LLC
Telephone: (801) 916-8188
AVonFoller@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
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.
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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:
-
- Indications for use
-
- Intended use
-
- Basic principles of operation
-
- 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.