(1 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a polyether impression material, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is classified as impression materials, which are used to reproduce the structure of teeth and gums for diagnostic and restorative purposes, not for treating a condition or disease.
No
The device is an impression material used to reproduce the structure of a patient's teeth and gums for the purpose of creating dental restorations, not to diagnose a medical condition.
No
The device description clearly states it is a polyether impression material consisting of two material components (pastes) and is used for creating physical impressions of teeth and gums. This is a physical material, 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 to create impressions of teeth and gums for dental restorations and functional impressions. This is a physical process for creating a mold, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is an impression material used to reproduce the structure of teeth and gums. This is a material used in a physical procedure, not a reagent or instrument used for in vitro testing.
- Classification: The device is classified as "impression materials (21 CFR 872.3660)". This classification falls under dental devices, not in vitro diagnostic devices.
- Performance Studies: The performance studies focus on the physical properties of the impression material (e.g., consistency, working time, detail reproduction, dimensional change, elastic recovery) and its compatibility with gypsum. These are characteristics relevant to its use in creating physical impressions, not to its ability to detect or measure substances in a biological sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device does not perform such a function.
N/A
Intended Use / Indications for Use
- · Impression of inlay, onlay, crown, bridge, and veneer preparations
- · Functional impressions
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
The polyether impression material Permadyne consists of the two material components lightbodied consistency and heavy-bodied consistency. It's classified as impression materials (21 CFR 872.3660) because it's intended to reproduce the structure of a patient's teeth and qums. Permadyne is a hand mixed (base paste/catalyst paste) impression material used in one step technique. Thereby Permadyne – Light Bodied Consistency is used as wash material in combination with Permadyne – Heavy Bodied Consistency as tray material. The mixing ratio is 7 volumes base paste :1 volume catalyst paste.
Permadyne – Light Bodied Consistency is a light-bodied polyether impression material. The base paste is blueish colored and the catalyst paste reddish colored.
Permadyne - Heavy Bodied Consistency is a heavy-bodied polyether impression material. The base paste is salmon colored and the catalyst paste reddish colored.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth and gums
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)
In vitro testing was conducted to show that the reformulated Permadyne fulfils the requirements of FDA recognized standard ISO 4823. Additionally, the reformulated Permadyne was compared to the predicate device Permadyne (K800031) regarding colors, mixing-time, consistency, working time, detail reproduction, linear dimensional change, compatibility with gypsum (type 3 / type 4 or 5), elastic recovery and strain in compression. The results of the reformulated Permadyne fulfill the requirements of ISO 4823 and are similar to Permadyne (K800031). In summary, 3M Deutschland GmbH concludes that the reformulated Permadyne is substantially equivalent to the predicate device regarding performance and physical and mechanical properties.
The biocompatibility assessment for the products was conducted in accordance with the following guidance:
US FDA Docket Number FDA-2013-D-0350. CDRH Document Number 1811-R1 - Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Guidance for Industry and Food and Drug Administration Staff (September 4, 2020)
ISO 10993-1 - 20018 - Evaluation and testing within a risk management process
ISO 10993-3 - 2014 - Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-5 - 2009 - Tests for in vitro cytotoxicity
ISO 10993-10 - 2010 - Tests for irritation and skin sensitization
ISO 10993-11 - 2017 - Tests for systemic toxicity
ISO 10993-12 - 2021 - Sample preparation and reference materials
ISO 10993-18 - 2020 - Chemical characterization of materials
ISO/TR 10993-22 - 2017 - Guidance on nanomaterials
ISO 10993-23 - 2021 - Tests for irritation
ISO 7405 - 2018 - Evaluation of biocompatibility of medical devices used in dentistry
The biocompatibility of Permadyne has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that Permadyne is safe for its intended use.
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.
Not Found
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
§ 872.3660 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 1, 2022
3M Deutschland GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220257
Trade/Device Name: Permadyne Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: Class II Product Code: ELW Dated: January 28, 2022 Received: January 31, 2022
Dear Prithul Bom:
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.
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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 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
Submission Number (if known)
Device Name
Permadyne
Indications for Use (Describe)
- · Impression of inlay, onlay, crown, bridge, and veneer preparations
- · Functional impressions
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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Carl-Schurz-Straße 1 41453 Neuss Germany
Postal Address: ESPE Platz 82229 Seefeld Germany
☎+49 (0)8152 700-0 鳥 +49 (0)8152 700-1366 Internet: www.3MESPE.de E-Mail: info3MESPE@3M.com WEEE-Req.-Nr. DE 36963167 VAT-ID: DE 120679179
510(k) Summary
| Submitter: | 3M Deutschland GmbH
ESPE Platz
82229 Seefeld
Germany
Establishment Registration Number: 9611385 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ruediger Franke
Regulatory Affairs Specialist
Phone: +49-8152-700 1802
Fax: +49-8152-700 1869
e-mail: ruediger.franke@3M.com |
| Date: | November 25, 2021 |
| Trade Name: | Permadyne |
| Common Name: | Polyether impression material |
| Classification Name: | Impression material
(21 CFR 872.3660, product code ELW) |
| Device Class: | Class II |
| Predicate Device: | Permadyne Polyether Rubber Impression (K800031) |
Description of Device
The polyether impression material Permadyne consists of the two material components lightbodied consistency and heavy-bodied consistency. It's classified as impression materials (21 CFR 872.3660) because it's intended to reproduce the structure of a patient's teeth and qums. Permadyne is a hand mixed (base paste/catalyst paste) impression material used in one step technique. Thereby Permadyne – Light Bodied Consistency is used as wash material in combination with Permadyne – Heavy Bodied Consistency as tray material. The mixing ratio is 7 volumes base paste :1 volume catalyst paste.
Permadyne – Light Bodied Consistency is a light-bodied polyether impression material. The base paste is blueish colored and the catalyst paste reddish colored.
Permadyne - Heavy Bodied Consistency is a heavy-bodied polyether impression material. The base paste is salmon colored and the catalyst paste reddish colored.
Image /page/3/Picture/11 description: The image shows a logo for the German Dental Industry. The logo consists of a stylized letter 'G' formed by concentric circles, with a triangular shape at the bottom. To the right of the symbol, the text 'Deutsche Dental Industrie' is written in a simple, sans-serif font, indicating the organization or industry the logo represents.
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Applicable Standards for Product Tests
- . ISO 4823:2015 Dentistry — Dentistry — Elastomeric Impression Materials
Indications for Use for Permadyne reformulated
- Impressions of inlay, onlay, crown, bridge, and veneer preparations
- . Functional impressions
Comparison
The reformulated Permadyne was compared to Permadyne (K800031) regarding indications for use, intended use, composition technology and physical and mechanical properties.
The tables below summarize the indications and technology of the reformulated Permadyne and the predicate device:
| Permadyne (K800031) | Permadyne reformulated |
|---|---|
| Polyether elastomeric impression material for | |
| crowns, bridges and edentulous impression | |
| procedures. | • Impression of inlay, onlay, crown, bridge, and |
| veneer preparations | |
| • Functional impressions |
Table Comparison of indications
| Technology | Permadyne (K800031) | Permadyne reformulated |
|---|---|---|
| Heavy-bodied and light-bodied material | ||
| components | × | × |
| Material family – Polyether impression | ||
| material | × | × |
| Material offered in tubes with base and | ||
| catalyst pastes | × | × |
| Manual mixing | × | × |
Table Comparison to predicate technology
Permadyne (K800031) and Permadyne reformulated, are both intend to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. Therefore, the intended use of the product is not affected by the change. The indications for use of Permadyne reformulated and the predicate device Permadyne (K800031) are clinically very similar. Permadyne is a precision impression material and therefore suitable for all kinds of impressions. The requirements of an impression material for inlay, onlay, crown, bridge and veneer preparations are comparable as all examples describe the impression of prepared teeth. The impression of an inlay, onlay or veneer don't require additional or other performance characteristics of the impression material than the impression of a crown or bridge. The procedure "functional impression" describes the impression technique that is used for
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edentulous and almost edentulous /partially dentate situations and is therefore don't describe a new condition compared to the edentulous impression procedures description of the predicate. Therefore, 3M Deutschland concludes that Permadyne reformulated is substantially equivalent to the predicate device Permadyne (K800031).
The reformulated Permadyne (K800031) are polyether impression materials containing reactive components, fillers, softeners, setting regulators, flavors, pigments and catalysts. 3M Deutschland GmbH is providing information to the Agency regarding information to FDA about the composition of the reformulated Permadyne and compared this to the predicate device. Considering the results of the biocompatibility evaluation of the reformulated Permadyne material components, it was shown that the new raw material does not have a negative influence on the biocompatibility of the materials. Also, the slightly different quantitative compositions of the reformulated material components in comparison to the predicate's composition submitted to the FDA in 1982 are covered by these favorable biocompatibility evaluations. In addition, the reformulated Permadyne material components fulfil the material performance requirements of ISO 4823:2015. No negative influence of the composition change on the material properties was observed. Therefore, 3M Deutschland GmbH concludes that Permadyne reformulated is substantially equivalent to the predicate device Permadyne (K800031) in technology.
In vitro testing was conducted to show that the reformulated Permadyne fulfils the requirements of FDA recognized standard ISO 4823. Additionally, the reformulated Permadyne was compared to the predicate device Permadyne (K800031) regarding colors, mixing-time, consistency, working time, detail reproduction, linear dimensional change, compatibility with gypsum (type 3 / type 4 or 5), elastic recovery and strain in compression. The results of the reformulated Permadyne fulfill the requirements of ISO 4823 and are similar to Permadyne (K800031). In summary, 3M Deutschland GmbH concludes that the reformulated Permadyne is substantially equivalent to the predicate device regarding performance and physical and mechanical properties.
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Biocompatibility
The biocompatibility assessment for the products was conducted in accordance with the following guidance:
| Guidance | Edition | Title |
|---|---|---|
| US FDA Docket Number | ||
| FDA-2013-D-0350. CDRH | ||
| Document Number 1811- | ||
| R1 | September 4, 2020 | Use of International Standard ISO 10993-1, Biological |
| evaluation of medical devices - Part 1: Evaluation and | ||
| testing within a risk management process - Guidance | ||
| for Industry and Food and Drug Administration Staff | ||
| ISO 10993-1 | 20018 | Evaluation and testing within a risk management |
| process | ||
| ISO 10993-3 | 2014 | Tests for genotoxicity, carcinogenicity and reproductive |
| toxicity | ||
| ISO 10993-5 | 2009 | Tests for in vitro cytotoxicity |
| ISO 10993-10 | 2010 | Tests for irritation and skin sensitization |
| ISO 10993-11 | 2017 | Tests for systemic toxicity |
| ISO 10993-12 | 2021 | Sample preparation and reference materials |
| ISO 10993-18 | 2020 | Chemical characterization of materials |
| ISO/TR 10993-22 | 2017 | Guidance on nanomaterials |
| ISO 10993-23 | 2021 | Tests for irritation |
| ISO 7405 | 2018 | Evaluation of biocompatibility of medical devices used |
| in dentistry |
The biocompatibility of Permadyne has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that Permadyne is safe for its intended use.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device."