(478 days)
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No
The summary describes a thermoplastic impression material and its physical and biological properties, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as an impression material used for making dental impressions, which is a diagnostic or procedural step, not a therapeutic treatment itself.
No
Explanation: The device is an impression material used for creating physical impressions, not for diagnosing medical conditions.
No
The device description clearly states it is a thermoplastic impression material available as a stick or wafer, indicating a physical material, not software.
Based on the provided information, No Stress Impress is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for taking impressions of anatomical structures (dentures, root surfaces, posts, etc.) for dental purposes. This is a physical process of creating a mold.
- Device Description: It's described as a thermoplastic impression material, a physical substance used to capture a shape.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a physiological state, health condition, or disease. IVDs are used for diagnostic purposes based on analyzing biological samples.
Therefore, No Stress Impress falls under the category of a dental impression material, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
No Stress Impress is a thermoplastic impression material available for full or partial impressions that comes as a stick or wafer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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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
1
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, DDS |
| President, No Stress Impress | |
| 2012 Scrimshaw Place | |
| Wilmington, North Carolina 28405 | |
| 917-304-7010 | |
| 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 for
Substantial
Equivalence |
|---------------------|--------------------------------------------------------|----------|-------------------------------------------------------------------|
| Primary Predicate | | | |
| Impression Compound | Sybron Dental
Specialties (acquired
by KavoKerr) | K110378 | • Same intended use
• Same Indications
• Similar technology |
| Description | No Stress Impress is a thermoplastic impression material
available for full or partial impressions that comes as a stick or
wafer. |
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Intended
Use/Indications
| for 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. |
|---|---|
| Technological | |
| Characteristics | 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 indications | |
| as the primary predicate. The ingredients are similar to the | |
| predicate. The labeling claims of the Subject device are the | |
| similar to those of the predicate. | |
| The labeling of the Subject device contains the similar warnings | |
| and precautions as those in the labeling of the predicates. | |
| Any differences that exist between the Subject device and the | |
| predicates have no significant effect on the safety or | |
| effectiveness. | |
| The Subject device is substantially equivalent to other | |
| prescription impression materials cleared in the US in terms of | |
| biocompatibility, technology, intended use, indications, and | |
| suitability characteristics. |