(85 days)
Not Found
No
The device description and performance studies focus on the physical and biocompatibility properties of plastic sheets, with no mention of AI or ML.
No.
The thermoforming sheet materials are used to create orthodontic and dental appliances, which are therapeutic, but the materials themselves are components, not the therapeutic device itself.
No
The device description indicates that Thermoforming Sheet Materials are used to create orthodontic and dental appliances, not to diagnose a condition. Their primary function is to be molded into a physical appliance.
No
The device is described as "pre-shaped flat plastic discs" and the performance studies focus on biocompatibility and physical properties, indicating it 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 for "orthodontic and dental appliances." This describes a device used directly on or in the patient's mouth for structural or corrective purposes.
- Device Description: The device is a "pre-shaped flat plastic disc" that is "plastified in appropriate thermoforming units and adapted onto patient individual plaster models." This process describes the creation of a physical appliance.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are typically used to test samples like blood, urine, or tissue to detect diseases, infections, or other medical conditions. This device is a material used to create a physical dental appliance.
N/A
Intended Use / Indications for Use
Thermoforming Sheet Materials Track A, B, E and Bleach are indication of orthodontic and dental appliances.
Product codes (comma separated list FDA assigned to the subject device)
MOC, MQC
Device Description
Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patient individual plaster models. After cooling the sheets are removed from the model and trimmed to fit. Thermoforming Sheet Materials include the following products:
- Track A
- Track B
- Track E
- Track bleach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical testing has been performed. All Thermoforming Sheet Materials are tested on their biocompatibility. The tests have been performed according to the standard EN ISO 10993-1 and FDA Guidance Document titled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The results of the testing demonstrated that the insolubility of the Thermoforming Sheet Materials is in compliance with EN ISO 10993-1 and the FDA Biocompatibility Guidance Document for the intended dental use.
No clinical testing was performed in support of this submission. The proposed device, Thermoforming Sheet Materials has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, Thermoforming Sheet Materials (K200125).
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
N/A
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2024
Bernhard Förster GmbH Stefan Förster CEO Westliche Karl-Friedrich-Strasse 151 Pforzheim, 75172 GERMANY
Re: K241311
Trade/Device Name: Thermoforming Sheet Materials (Track A): Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
Regulatory Class: Unclassified Product Code: MOC Dated: May 9, 2024 Received: May 9, 2024
Dear Stefan Förster:
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 (OS) 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.
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 medical devices and radiation-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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, 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
510(k) Number (if known) K241311
Device Name
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
Indications for Use (Describe)
Thermoforming Sheet Materials Track A, B, E and Bleach are indication of orthodontic and dental appliances.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for FORESTADENT. The logo consists of a gold-colored arc above the word "FORESTADENT," which is written in a bold, sans-serif font. Below the word "FORESTADENT" is the phrase "GERMAN PRECISION IN ORTHODONTICS."
GERMAN PRECISION IN ORTHODONTICS
K241311 - 510(k) Summary
Prepared July 30, 2024
| I) | Applicant | |
|---|---|---|
| Submitter | ||
| Address | FORESTADENT Bernhard Förster GmbH | |
| Westliche Karl-Friedrich-Strasse 151 | ||
| Pforzheim - Germany. | ||
| Contact | Mr. Stefan Förster | |
| Telephone | +497231459116 | |
| Stefan.Foerster@forestadent.com | ||
| II) | Device | |
| Trade Name | Thermoforming Sheet | |
| Materials (Track A); | ||
| Thermoforming Sheet | ||
| Materials (Track B); | ||
| Thermoforming Sheet | ||
| Materials (Track E); | ||
| Thermoforming Sheet | ||
| Materials (Track Bleach) | ||
| Common Name | Thermoforming Sheet Materials | |
| Classification Name | Mouthguard, Prescription | |
| Regulation Number | Unclassified | |
| Product Code | MQC | |
| III) | Predicate Device | |
| 510(k) Number | K200125 | |
| Applicant | Erkodent Erich Kopp GmbH | |
| Trade Name | Erkoloc-pro (blu / green / pink) | |
| Erkodur (freeze / -0M1 /-A1 / -A2 / -A3) | ||
| Erkoflex (color / freestyle / -95 / -bleach) | ||
| Erkolign | ||
| Erkoplast PLA (-T/-W/-R) | ||
| Erkolen | ||
| Playsafe triple (-light) | ||
| Classification Name | Mouthguard, Prescription | |
| Regulation Number | Unclassified | |
| Product Code | MQC, KMY |
- IV) Indication For Use
Thermoforming Sheet Materials Track A, B, E and Bleach are indicated for the fabrication of orthodontic and dental appliances.
5
Image /page/5/Picture/0 description: The image shows the logo for FORESTA DENT, a company specializing in German precision in orthodontics. The logo features a stylized, curved line above the company name, with the letters in a combination of black and gold. The registered trademark symbol is visible to the right of the company name. The text "GERMAN PRECISION IN ORTHODONTICS" is located below the company name.
GERMAN PRECISION IN ORTHODON
- V) Device Description
Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patient individual plaster models. After cooling the sheets are removed from the model and trimmed to fit. Thermoforming Sheet Materials include the following products:
Thermoforming Sheet Materials:
- Track A
- Track B
- Track E
- Track bleach.
VI) Comparison of Technological Characteristics
| ITEM | PREDICATE DEVICE
ERKODENT
(K200125) | PROPOSED DEVICE
FORESTANDENT TRACK | COMPARISON
RESULT |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------|
| FDA
Product
Code | MQC | MQC | same |
| FDA
Device
Classification
Name | Mouthguard, Prescription | Mouthguard, Prescription | same |
| Indications for
Use | Thermoforming Sheet Materials
are indicated for the fabrication
of orthodontic and dental
appliances | Thermoforming
Sheet
Materials are indicated for
the fabrication of orthodontic
and dental appliances | same |
| Material | Resin / Thermoplastic | Resin / Thermoplastic | same |
| Fabrication | Thermo-Molding Custom-Fit | Thermo-Molding Custom-Fit | same |
| Prescription
Device | Yes | Yes | same |
| Re-Usable
Device | Yes, Single Consumer/Patient | Yes, Single Consumer/Patient | same |
| Sterility | Non-Sterile | Non-Sterile | same |
| Biocompatible | Yes | Yes | same |
The above information demonstrates that, for the purposes of FDA regulation of medical devices, the TRACK A, TRACK BLEACH, TRACK E and TRACK B thermoforming sheet materials is substantially equivalent in terms of principles, indications and design to the legally marketed K200125 predicate: ERKODENT thermoforming sheet materials.
- VII) Summary of Non-Clinical Testing Non-clinical testing has been performed. All Thermoforming Sheet Materials are tested on their biocompatibility.
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Image /page/6/Picture/0 description: The image shows the word "FORESTADENT" in a stylized font. The letters "FORESTA" are in black, while the letters "DENT" are in a gold color. There is a gold arc above the letters "FORESTA".
GERMAN PRECISION IN ORTHODONTICS
The tests have been performed according to the standard EN ISO 10993-1 and FDA Guidance Document titled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The results of the testing demonstrated that the insolubility of the Thermoforming Sheet Materials is in compliance with EN ISO 10993-1 and the FDA Biocompatibility Guidance Document for the intended dental use.
| water absorption 24h/23 °C | ISO 62/1 |
|---|---|
| density | ISO 1183 |
| tensile strength | ISO 527 |
| flectional strength | ISO 178 |
| impact strength 23°C | ISO 179/1eU |
| Notch impact 24 °C | ISO 179/1eA |
| yield stress | ISO 527 |
| elongation at break | ISO 527 |
| E-modulus | ISO 527 |
| hardness Shore | ISO 868 |
| ball indentation hardness | ISO 2039/1 |
| Vicat softening point | ISO 11357/3 |
| temperature resistance | ISO 75/A |
| glass transition temperature | ISO 11357/3 |
Physical properties have been tested according to the applicable standards:
VIII) Summary of Clinical Testing
No clinical testing was performed in support of this submission.
IX) Conclusion
The proposed device, Thermoforming Sheet Materials has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, Thermoforming Sheet Materials (K200125).
These devices are substantially equivalent, and there is no difference between the proposed subject device and the cited predicate device.