(281 days)
No
The device description and performance studies focus on the physical and biological properties of the material, with no mention of AI or ML.
No
This device is a material used to fabricate appliances, not a therapeutic device itself.
No
The device is described as thermoforming sheet materials used for fabricating orthodontic and dental appliances, which is a manufacturing or prosthetic purpose, not for diagnosing conditions.
No
The device description clearly states it is a physical product (pre-shaped flat plastic discs) used in a thermoforming process, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the fabrication of orthodontic and dental appliances." This describes a device used in the creation of a medical device (dental appliances), not a device used to perform a diagnostic test on a sample from the human body.
- Device Description: The description details a physical material (plastic sheets) that is shaped and adapted onto a model. This is a manufacturing process, not a diagnostic process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility and physical properties of the material, which are relevant for a material used in medical devices, but not for an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Thermoforming sheet materials are indicated for the fabrication of orthodontic and dental appliances.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
Device Description
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.
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 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).
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.
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 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
1
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
2
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)
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3
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 3 |
| 72285 Pfalzgrafenweiler | |
| Germany | |
| Company Phone: | +49 74 45 85 01-0 |
| Company Fax: | +49 74 45 85 01-15 |
| Contact Person: | Hans-Peter Kopp |
| Heidrun 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:
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.
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 Sheet
Materials and Accessories
Dentsply International, Inc.
(K072522) | Predicate Device
(Reference)
Mouthguard and Aligner
Materials
Dentsply International,
Inc.
(K062828) | Proposed Device
Thermoforming
Sheet Materials
ERKODENT |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| FDA Product
Code | MQC, NXC | MQC, NXC, KMY | MQC, KMY |
| | Predicate Device (Primary)
Thermoform Sheet
Materials and Accessories
Dentsply International, Inc.
(K072522) | Predicate Device
(Reference)
Mouthguard and Aligner
Materials
Dentsply International,
Inc.
(K062828) | Proposed Device
Thermoforming
Sheet Materials
ERKODENT |
| Attributes | | | |
| FDA Device
Classification
Name | Mouthguard,
Prescription | Mouthguard,
Prescription | Mouthguard,
Prescription |
| Indications for
Use | THERMOFORM SHEET
MATERIALS AND
ACCESSORIES are
indicated for the
fabrication of orthodontic
and dental appliances. | MOUTHGUARD AND
ALIGNER MATERIALS are
indicated for the fabrication
of
orthodontic and dental
appliances such as
aligners, bite planes,
mouthguards, nightguards,
snoring appliances, splints,
retainers, repositioners,
and temporary bridges. | THERMOFORMING
SHEET MATERIALS
are indicated for
the fabrication of
orthodontic and
dental appliances |
| Material | Resin/Thermoplastic | Resin/Thermoplastic | Resin/Thermoplastic |
| Fabrication | Thermo-Molding
Custom-Fit | Thermo-Molding
Custom-Fit | Thermo-Molding
Custom-Fit |
| Prescription
Device | Yes | Yes | Yes |
| Re-Usable
Device | Yes, Single
Consumer/Patient | Yes, Single
Consumer/Patient | Yes, Single
Consumer / 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
The proposed device, Thermoforming Sheet Materials has the same performance specifications, fundamental scientific technology and intended use as that of the predicate devices. Thermoform Sheet Materials and Accessories (K072522) and Mouthguard and Aligner Materials (K062828).
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.