Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patients individual plaster models. After cooling the sheets are removed from the model and trimmed to fit.

AI/ML Overview

The provided FDA 510(k) clearance document for "Thermoforming Sheet Materials" (K200125) describes non-clinical testing for biocompatibility and physical properties, but it does not contain information about a study involving acceptance criteria related to a device's performance that would require a test set, ground truth established by experts, or MRMC studies.

This submission is for a material (thermoforming sheets) used to fabricate orthodontic and dental appliances, not a diagnostic or AI-driven device. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted and a clear indication of what is not present in the document based on the device type:

1. A table of acceptance criteria and the reported device performance

The document provides a list of standards the materials were tested against, implying that meeting these standards constitutes the acceptance criteria. The reported performance is that the materials are in compliance with these standards for biocompatibility and that physical properties were tested.

Acceptance Criteria (Implied by Standard Compliance)	Reported Device Performance
Compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 (Biocompatibility)	Insolubility of the Thermoforming Sheet Materials is in compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 for the intended dental use. Biological effects considered for leachables (cytotoxicity, mucosa irritation, sensitization, acute systemic and subchronic toxicity, genotoxicity) were evaluated.
Compliance with Physical Property Standards (e.g., ISO 62/1 for water absorption, ISO 1183 for density, ISO 527 for tensile strength, etc.)	Physical properties have been tested according to the applicable standards (listed in the document). The document concludes that the proposed device has "the same performance specifications" as the predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for the non-clinical tests.
Data Provenance: Not specified. The company is based in Germany, so tests may have been conducted there or by a contract lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is a material, not a diagnostic device requiring expert interpretation of results. The "ground truth" here is compliance with established material science and biocompatibility standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a material, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For biocompatibility: Adherence to established international and FDA-specific guidance documents and standards (EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350) which involve specific chemical and biological assays.
For physical properties: Adherence to material testing standards (e.g., various ISO standards) which involve quantifiable measurements.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not Applicable.

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 28, 2020

Erkodent Erich Kopp GmbH % Jon Ward President and CEO AJW Technology Consultants, Inc. 11705 Boyette Road, Suite 503 Riverview, Florida 33569

Re: K200125

Trade/Device Name: Thermoforming Sheet Materials Regulatory Class: Unclassified Product Code: MQC, KMY Dated: July 27, 2020 Received: July 30, 2020

Dear Jon Ward:

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 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

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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 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).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K200125

Device Name Thermoforming Sheet Materials

Indications for Use (Describe)

Thermoforming Sheet Materials are indicated for the fabrication of orthodontic and dental appliances.

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.

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Image /page/3/Picture/0 description: The image shows the logo for ERKODENT. The logo features a blue stylized letter "E" with a sharp, angular design, followed by the word "ERKODENT" in a bold, blue sans-serif font. A registered trademark symbol is present to the right of the word.

K200125

006 510(k) Summary

[As required by 21 CFR 807.92]

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

A. Submitter Information

Company Name:	Erkodent Erich Kopp GmbH
Company Address:	Siemensstrasse 372285 PfalzgrafenweilerGermany
Company Phone:	+49 74 45 85 01-0
Company Fax:	+49 74 45 85 01-15
Contact Person:	Hans-Peter KoppHeidrun Müller

Date Summary Prepared: 28 October 2020

B. Regulatory Correspondent

AJW Technology Consultants, Inc 11705 Boyette Road,Suite #503 Riverview, FL 33569, USA Phone: 813-645-2855 Contact Person: Jon Ward Email: wardjp@ajwtech.com

C. Device Identification

Generic name:	Thermoforming Sheet Materials
Specific trade names(Model names):	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
Product Code:	MQC
21 CFR Reference:	Unclassified
Subsequent product codes:	KMY, 21 CFR Reference: 872.5525
Panel:	Dental

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Image /page/4/Picture/0 description: The image shows the logo for ERKODENT. The logo features a blue stylized letter E on the left, followed by the word "ERKODENT" in blue, with a registered trademark symbol next to it. A blue line runs underneath the letter and the word.

D. Identification of Predicate Device

Predicate Devices: Primary predicate:

Thermoform Sheet Materials and Accessories, K072522 Reference device: Mouthguard and Aligner Materials K062828

E. Device Description:

F. Indications for use

Thermoforming sheet materials are indicated for the fabrication of orthodontic and dental appliances.

G. Technological characteristics

All of the components found in Thermoforming Sheet Materials have been used in leqally marketed devices and/or were found safe for dental use. The Thermoforming Sheet Materials have been tested on their biocompatibility.

The proposed device, Thermoforming Sheet Materials has the same performance specifications, fundamental scientific technology and intended use as that of the predicate devices and is therefore substantially equivalent.

H. Comparison table: Predicate Devices and Proposed Device

Attributes	Predicate Device (Primary)Thermoform SheetMaterials and AccessoriesDentsply International, Inc.(K072522)	Predicate Device(Reference)Mouthguard and AlignerMaterialsDentsply International,Inc.(K062828)	Proposed DeviceThermoformingSheet MaterialsERKODENT
FDA ProductCode	MQC, NXC	MQC, NXC, KMY	MQC, KMY
	Predicate Device (Primary)Thermoform SheetMaterials and AccessoriesDentsply International, Inc.(K072522)	Predicate Device(Reference)Mouthguard and AlignerMaterialsDentsply International,Inc.(K062828)	Proposed DeviceThermoformingSheet MaterialsERKODENT
Attributes
FDA DeviceClassificationName	Mouthguard,Prescription	Mouthguard,Prescription	Mouthguard,Prescription
Indications forUse	THERMOFORM SHEETMATERIALS ANDACCESSORIES areindicated for thefabrication of orthodonticand dental appliances.	MOUTHGUARD ANDALIGNER MATERIALS areindicated for the fabricationoforthodontic and dentalappliances such asaligners, bite planes,mouthguards, nightguards,snoring appliances, splints,retainers, repositioners,and temporary bridges.	THERMOFORMINGSHEET MATERIALSare indicated forthe fabrication oforthodontic anddental appliances
Material	Resin/Thermoplastic	Resin/Thermoplastic	Resin/Thermoplastic
Fabrication	Thermo-MoldingCustom-Fit	Thermo-MoldingCustom-Fit	Thermo-MoldingCustom-Fit
PrescriptionDevice	Yes	Yes	Yes
Re-UsableDevice	Yes, SingleConsumer/Patient	Yes, SingleConsumer/Patient	Yes, SingleConsumer / Patient
Sterility	Non-Sterile	Non-Sterile	Non-Sterile
Biocompatible	Yes	Yes	Yes

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Image /page/5/Picture/0 description: The image shows the logo for ERKODENT. The logo features a blue stylized letter "E" followed by the text "ERKODENT" in blue. A registered trademark symbol is located to the right of the word "ERKODENT".

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Image /page/6/Picture/0 description: The image shows the Erkodent logo. The logo consists of a blue stylized letter E on the left, followed by the word "ERKODENT" in blue, and a registered trademark symbol in a circle on the right. A blue line underlines the entire logo.

1. Non-Clinical Testing

Non-clinical testing have 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 No. FDA-2013-D-0350. Biological effects to be considered for leachables are cytotoxicity, mucosa irritation, sensitization, acute systemic and subchronic toxicity, genotoxicity.

The results of the testing prove that the insolubility of the Thermoforming Sheet Materials is in compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 for the intended dental use.

Physical properties have been tested according to the applicable standards:

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

J. Conclusion of the testing

These devices are substantially equivalent, and any differences between the proposed device Thermoform Sheet Materials and Accessories and the cited predicate devices do not introduce any new issues.

Regulation Number and Section

N/A