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.

AI/ML Overview

The provided text is a 510(k) summary for Thermoforming Sheet Materials. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for device performance in the context of an AI/algorithm-based medical device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not available in the provided document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria for device performance that would typically be associated with an AI/algorithm. Instead, it demonstrates compliance with international standards for biocompatibility and provides a list of physical properties that were tested according to other ISO standards.

Acceptance Criteria (Not explicitly stated as such for performance, but as compliance to standards)	Reported Device Performance (Summary of compliance)
Biocompatibility (according to EN ISO 10993-1 and FDA Guidance)	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.
Physical Properties (according to various ISO standards as listed)	"Physical properties have been tested according to the applicable standards." (No specific values reported in this summary).

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

Not applicable. This device is a material, not an AI/algorithm that uses a test set of data. The testing mentioned in the document relates to material characterization.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth is a concept related to labeling data for AI/algorithm development and evaluation. This document describes physical material testing.

4. Adjudication Method:

Not applicable. This is relevant for establishing ground truth in AI/algorithm studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study assesses human performance with and without AI assistance, which is not relevant for a material-based device.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is not an algorithm.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" here would be the physical properties and biocompatibility of the material itself, determined through standard laboratory tests, not expert consensus or pathology on a dataset.

8. Sample Size for the Training Set:

Not applicable. This device is a material, not an AI/algorithm that requires a training set.

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

Not applicable.

Summary from the provided document:

The provided document details a 510(k) premarket notification for Thermoforming Sheet Materials. The focus is on demonstrating substantial equivalence to an existing predicate device (K200125 from Erkodent Erich Kopp GmbH). The core of the justification is that the proposed device, the Thermoforming Sheet Materials, are similar in:

Indications for Use: Fabrication of orthodontic and dental appliances.
Material: Resin / Thermoplastic.
Fabrication Method: Thermo-Molding Custom-Fit.
Prescription Device: Yes.
Re-Usable Device: Yes, single consumer/patient.
Sterility: Non-Sterile.
Biocompatibility: Yes.

Non-Clinical Testing: The document states that non-clinical testing was performed for biocompatibility according to EN ISO 10993-1 and FDA Guidance, and physical properties according to various ISO standards. The results demonstrated compliance for biocompatibility. Specific numerical values for the physical properties were not provided in this summary.

Clinical Testing: No clinical testing was performed in support of this submission.

In conclusion, the document does not contain the type of acceptance criteria and study information typically found for AI/algorithm-based medical devices. It is a regulatory submission for a physical material, demonstrating equivalence to a lawfully marketed predicate.

Summary

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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.

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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).

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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

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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
	SubmitterAddress	FORESTADENT Bernhard Förster GmbHWestliche Karl-Friedrich-Strasse 151Pforzheim - Germany.
	Contact	Mr. Stefan Förster
	Telephone	+497231459116
	E-mail	Stefan.Foerster@forestadent.com
II)	Device
	Trade Name	Thermoforming SheetMaterials (Track A);Thermoforming SheetMaterials (Track B);Thermoforming SheetMaterials (Track E);Thermoforming SheetMaterials (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)ErkolignErkoplast PLA (-T/-W/-R)ErkolenPlaysafe 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.

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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 DEVICEERKODENT(K200125)	PROPOSED DEVICEFORESTANDENT TRACK	COMPARISONRESULT
FDAProductCode	MQC	MQC	same
FDADeviceClassificationName	Mouthguard, Prescription	Mouthguard, Prescription	same
Indications forUse	Thermoforming Sheet Materialsare indicated for the fabricationof orthodontic and dentalappliances	ThermoformingSheetMaterials are indicated forthe fabrication of orthodonticand dental appliances	same
Material	Resin / Thermoplastic	Resin / Thermoplastic	same
Fabrication	Thermo-Molding Custom-Fit	Thermo-Molding Custom-Fit	same
PrescriptionDevice	Yes	Yes	same
Re-UsableDevice	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.

Regulation Number and Section

N/A