(98 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental impression material, with no mention of AI or ML.
No
The device, Speedex, is an impression material used to record the physical situation in a patient's mouth for dental repairs or replacements. It is not used to treat or cure a disease or condition.
No
This device is an impression material used to record the physical situation in a patient's mouth for the purpose of repairing, reshaping, or replacing teeth, not to diagnose a medical condition.
No
The device description clearly states it is a two-component impression material based on polysiloxanes, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Speedex materials are used to create physical impressions of a patient's mouth. This is a mechanical process for recording the physical shape of the teeth and surrounding structures.
- Intended Use: The intended uses listed are all related to creating physical models or impressions for dental procedures (prosthetics, orthodontics, study models, etc.). None of these involve analyzing biological samples for diagnostic purposes.
- Device Description: The description clearly states it's an "impression material" used to "record the current physical situation in a patient's mouth."
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, Speedex is a dental impression material, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Speedex putty/putty soft
- Primary impression in the putty-wash Impression technique
- Pick-up impression in the simultaneous mixing technique
- Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses
Speedex light body
- Correction material for the correction impression technique
- Syringe material for the two-phase impression technique
- Impression material for relining
Speedex medium
- Complete and partial prosthetics, correction material for the correction impression technique
- Monophase impression technique, simultaneous mixing technique
- Liner impression material
Speedex Universal Activator
- Activator for Speedex putty; Speedex putty soft; Speedex light body; Speedex medium, for creating dental impressions
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Speedex is two-component impression material based on polysiloxanes. Speedex is intended for the recording of the current physical situation in a patient's mouth for the purpose of repairing, reshaping or replacing the patient's teeth. After mixing of a base and activator, the Speedex Materials form pastes which are used individually or in combination as antal impression material, usually together with a standard commerical or individual impression tray, using conventional impression techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth
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)
Performance testing as was conducted to verify that the device comples with the requirements of ISO 4823:2021, and the same testing was carried out on the predicate device to help establish substantial equivalence. These tests include consistency, working time, detail reproduction, linear dimensional change, compatibility with gypsum, elastic recovery, and strain in compression. Additionally biocompatibility testing to the requirements of ISO 10993-5 and 10993-10 as well as shelf life testing was carried out.
Based on the non-clinical performance data, the proposed device Speedex is as safe, as effective and performs as well as the predicate Device PRESIDENT the Original.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2024
Dent4You AG Oliver Ashe Regulatory Affairs Manager Bahnhofstrasse 2 Heerbrugg. SG 9435 Switzerland
Re: K242360
Trade/Device Name: Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: August 9, 2024 Received: August 9, 2024
Dear Oliver Ashe:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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., RAC, CQIA 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
3
Indications for Use
| Submission Number (if known) | K242360 |
|---|---|
| Device Name | Speedex Light Body; |
| Speedex Medium; | |
| Speedex Putty; | |
| Speedex Putty Soft; | |
| Speedex Universal Activator | |
| Indications for Use (Describe) | Speedex putty/putty soft Primary impression in the putty-wash Impression techniquePick-up impression in the simultaneous mixing techniqueImpressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses |
| Speedex light body Correction material for the correction impression techniqueSyringe material for the two-phase impression techniqueImpression material for relining | |
| Speedex medium Complete and partial prosthetics, correction material for the correction impression techniqueMonophase impression technique, simultaneous mixing techniqueLiner impression material | |
| Speedex Universal Activator Activator for Speedex putty; Speedex putty soft; Speedex light body; Speedex medium, for creating dental 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| 510(k) #: | K242360 | 510(k) Summary | Prepared on: 2024-08-15 |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Dent4 YouAG | ||
| Applicant Address | Bahnhofstrasse 2 Heerbrugg SG 9435 Switzerland | ||
| Applicant Contact Telephone | 4 171 757 54 24 | ||
| Applicant Contact | Mr. Oliver Ashe | ||
| Applicant Contact Email | oliver.ashe@coltene.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Speedex Light Body; | ||
| Speedex Medium; | |||
| Speedex Putty; | |||
| Speedex Putty Soft; | |||
| Speedex Universal Activator | |||
| Common Name | Impression material | ||
| Classification Name | Material, Impression | ||
| Regulation Number | 872.3660 | ||
| Product Code(s) | ELW | ||
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K220097 | PRESIDENT The Original | ELW | |
| Device Description Summary 21 CFR 807.92(a)(4) | |||
| Speedex is two-component impression material based on polysiloxanes. Speedex is intended for the recording of the current physical situation in a patient's mouth for the purpose of repairing, reshaping or replacing the patient's teeth. After mixing of a base and activator, the Speedex Materials form pastes which are used individually or in combination as antal impression material, usually together with a standard commerical or individual impression tray, using conventional impression techniques. | |||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | ||
| Speedex putty/putty soft | |||
| Primary impression in the putty-wash Impression technique |
- Pick-up impression in the simultaneous mixing technique
- Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses
Speedex light body
Correction material for the correction impression technique - Syringe material for the two-phase impression technique
Impression material for relining | | | |
| Speedex medium | | | |
5
-
Complete and partial prosthetics, correction material for the correction impression technique
-
Monophase impression technique, simultaneous mixing technique
-
Liner impression material
Speedex Universal Activator
- Activator for Speedex putty soft; Speedex light body; Speedex medium, for creating dental impressions
Indications for Use Comparison
The indications for use are similar between the subject device and predicate.
Technological Comparison
Speedex (subject device) and PRESIDENT the Original (predicate device) are both two component room temperature vulcanising silicones, provided in a range of viscosities with the same intended use. The precise composition of the two devices represents a technological difference. Speedex is composed of polysiloxanes and filler materials, whereas PRESIDENT the Original consists of polyvinylsloxanes and filler materials. This different questions of safety and effectiveness between the subject and predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance testing as was conducted to verify that the device comples with the requirements of ISO 4823:2021, and the same testing was carried out on the predicate device to help establish substantial equivalence. These tests include consistency, working time, detail reproduction, linear dimensional change, compatibility with gypsum, elastic recovery, and strain in compression. Additionally biocompatibility testing to the requirements of ISO 10993-5 and 10993-10 as well as shelf life testing was carried out.
Based on the non-clinical performance data, the proposed device Speedex is as safe, as effective and performs as well as the predicate Device PRESIDENT the Original.