No Stress Impress is intended for use as a rebasing and relining impression material as well as for general impressions including but not limited to dentures, root surfaces, and posts.

Device Description

No Stress Impress is a thermoplastic impression material available for full or partial impressions that comes as a stick or wafer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "No Stress Impress" device, broken down as requested.

The document is a 510(k) Summary for a dental impression material. As such, the "acceptance criteria" are mainly focused on product performance standards and biocompatibility, rather than clinical efficacy metrics typical of AI/software devices. The "study" refers to the testing performed to demonstrate compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Reported Device Performance (Results)
Material testing per ISO 4823:2015, 7.8 Dentistry Elastomeric Material	Satisfactory results
Biocompatibility Testing:
ISO Oral Mucosal Irritation Study in Hamsters - Collar Method - 24 hours	Non-irritating
ISO Guinea Pig Maximization Sensitization Test	Non-sensitizing
Cytotoxicity Study Using the ISO Elution Method	No lysis, no reactivity, no pH shift
Cytotoxicity Study Using the ISO Agarose Overlay Method	No lysis, no reactivity

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

The document does not specify sample sizes for the material testing per ISO 4823:2015.
For biocompatibility testing, the following "sample sizes" are implied by the test names, but precise numerical counts of animals/cells are not given:

Hamsters (for Oral Mucosal Irritation Study)
Guinea Pigs (for Sensitization Test)
Cell cultures (for Cytotoxicity Studies)

The data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified in the provided text.

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

This type of information is not applicable to the "No Stress Impress" device as described in this 510(k) summary. The device is a material, not an AI or diagnostic tool that requires expert interpretation for ground truth establishment. The ground truth for material properties is established by adherence to international standards (e.g., ISO) and laboratory test results.

4. Adjudication Method for the Test Set

This information is not applicable as the device is a material, not a diagnostic or AI device that requires adjudication of expert opinions. The "ground truth" for material properties is determined by the specific outcomes of the standardized tests.

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

This information is not applicable to the "No Stress Impress" device. This is a material, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable to the "No Stress Impress" device. It is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

Material properties and performance standards: Compliance with ISO 4823:2015 for dentistry elastomeric material.
Biocompatibility test results: Specific empirical outcomes from standardized biological assays (irritation, sensitization, cytotoxicity) conducted according to ISO 10993-1.

8. The Sample Size for the Training Set

This information is not applicable to this device. As a dental impression material, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable to this device for the reasons stated above.

Summary

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January 19, 2023

No Stress Impress LLC % Cheryl Wagoner Consultant Wagoner Consulting LLG 5215 Crosswinds Drive Wilmington, North Carolina 28409

Re: K213175

Trade/Device Name: No Stress Impress Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: December 6, 2022 Received: December 7, 2022

Dear Cheryl Wagoner:

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,

Bobak Shirmohammadi -S

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213175

Device Name No Stress Impress

Indications for Use (Describe)

No Stress Impress is intended for use as a rebasing and relining impression material as well as for general impressions including but not limited to dentures, root surfaces, and posts.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(as required by 21 CFR 807.92)

Submitter	No Stress Impress
Contact Person	Misael Otero, DDSPresident, No Stress Impress2012 Scrimshaw PlaceWilmington, North Carolina 28405917-304-7010
Date Prepared	April 25, 2022

Trade Name	No Stress Impress
Common Name	Impression material
Classification	21 CFR §872.3660, Product Code ELW
Class	Class II

Product name	Manufacturer	510(k) #	Basis forSubstantialEquivalence
Primary Predicate
Impression Compound	Sybron DentalSpecialties (acquiredby KavoKerr)	K110378	• Same intended use• Same Indications• Similar technology

Description	No Stress Impress is a thermoplastic impression materialavailable for full or partial impressions that comes as a stick orwafer.
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IntendedUse/Indicationsfor Use	No Stress Impress is intended for use as a rebasing and relining impression material as well as for general impressions including but not limited to dentures, root surfaces, and posts.
TechnologicalCharacteristics	This product is made ingredients similar to ingredients found in other impression materials currently on the U.S. markets and substantially equivalent to the predicate devices.

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Performance Data	Material testing per ISO 4823:2015, 7.8 Dentistry Elastomeric Material was conducted with satisfactory results.
	Biocompatibility testing was performed in accordance with ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing” including:
	Test Performed	Results
	ISO Oral Mucosal Irritation Study in Hamsters -Collar Method - 24 hours	Non-irritating
	ISO Guinea Pig Maximization Sensitization Test	Non-sensitizing
	Cytotoxicity Study Using the ISO Elution Method	No lysis, no reactivity, no pH shift
	Cytotoxicity Study Using the ISO Agarose Overlay Method	No lysis, no reactivity

Conclusion
	The Subject device has identical intended use and indicationsas the primary predicate. The ingredients are similar to thepredicate. The labeling claims of the Subject device are thesimilar to those of the predicate.
	The labeling of the Subject device contains the similar warningsand precautions as those in the labeling of the predicates.
	Any differences that exist between the Subject device and thepredicates have no significant effect on the safety oreffectiveness.
	The Subject device is substantially equivalent to otherprescription impression materials cleared in the US in terms ofbiocompatibility, technology, intended use, indications, andsuitability characteristics.

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).