(284 days)
No
The device description and intended use focus on the material properties and fabrication method (heat curing or CAD/CAM milling) of a dental appliance material. There is no mention of AI or ML in the provided text.
No
This device is a material system used for fabricating dental appliances, not an appliance itself that directly provides therapy. The function is for manufacturing, not therapy.
No
The device is described as an acrylic compound system for fabricating dental appliances like mouthguards and splints, and its description and performance studies focus on mechanical properties rather than diagnostic capabilities.
No
The device description clearly indicates the device is a physical material (powder/liquid and blanks) used in the fabrication of dental appliances, not a software program.
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 dental appliances (mouthguards, splints). This is a mechanical/physical application within the mouth, not a diagnostic test performed on biological samples outside the body.
- Device Description: The device is a material (powder/liquid or blank) used to create physical objects. It doesn't involve analyzing biological samples.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a material used in the manufacturing of medical devices (dental appliances), but it is not a diagnostic device itself.
N/A
Intended Use / Indications for Use
Thermeo powder / Thermeo liquid is a heat cured, moldable, acrylic compound system for use in the fabrication of dental appliances such as mouthguards, bruxism and TMJ splint appliances, and bite splints.
The Thermeo blank is a disc intended for the fabrication of dental appliances such as mouthguards, buxism and TMJ splint appliances, and bite splints using CAD/CAM milling machines.
Product codes
MQC
Device Description
The Thermeo powder/Thermeo liquid is a two-compound mixable device, containing a powder component and a liquid component. The device is heat cured for the fabrication of dental appliances.
The Thermeo blanks are pre-made by pro3dure using the two-part mixable device. The Thermeo blank is intended to be used in conjunction with CAD/CAM milling technology systems.
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)
Performance testing for the Thermeo System was performed in accordance with ISO 20795-2 including Flexural modulus, Flexural Strength, Tensile Strength, and Elongation at Break.
Biocompatibility testing was conducted in accordance with ISO 10993-1.
The shelf life of the Thermeo System is 2 years. Testing was performed in accordance with ASTM F1980-16.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
April 8, 2022
Pro3dure Medical GmbH Frank Gischer Technical Director Am Burgberg 13 Iserlohn, 58642 DEU GERMANY
Re: K212017
Trade/Device Name: Thermeo System Regulatory Class: Unclassified Product Code: MQC Dated: February 28, 2022 Received: March 10, 2022
Dear Frank Gischer:
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/cfpmp/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 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
1
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,
Michael E. Adjodha, M.ChE. 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
2
Indications for Use
510(k) Number (if known) K212017
Device Name Thermeo System
Indications for Use (Describe)
Thermeo powder / Thermeo liquid is a heat cured, moldable, acrylic compound system for use in the fabrication of dental appliances such as mouthguards, bruxism and TMJ splint appliances, and bite splints.
The Thermeo blank is a disc intended for the fabrication of dental appliances such as mouthguards, buxism and TMJ splint appliances, and bite splints using CAD/CAM milling machines.
| 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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5. 510(k) Summary
| 510(k) Number: | K212017 |
|---|---|
| Device Trade Name: | Thermeo System |
| Manufacturer: | Pro3dure Medical GmbH |
| Am Burgberg 13 | |
| 58642 Iserlohn | |
| Germany | |
| Contact: | Mr. Frank Gischer |
| Phone: +49 (0)2374 920050-14 | |
| Fax: +49 (0)2374 920050-50 | |
| Frank.gischer@pro3dure.com | |
| Prepared by: | Ms. Patricia Kontoudis |
| Consultant, Regulatory Affairs 804 | |
| Umbra St.Baltimore, MD, 21224 | |
| Phone: (443)722-0126 | |
| pkontoudis@gmail.com | |
| Date Prepared: | April 1, 2022 |
| Classification: | Unclassified |
| Product Codes: | MQC |
| Primary Predicate Device: | Astron Dental Clearsplint ES (K111828) |
| Additional Predicate Device: | New Stetic S.A. Portux CAD/CAM Disc (K192153) |
| Reference Device: | Pro3dure GR-17 Resin System (K201827) |
| Pro3dure GR Splint Resin System (K211415). | |
| Indications for Use: | Thermeo powder / Thermeo liquid is a heat cured, |
| moldable, acrylic compound system for use in the | |
| fabrication of dental appliances such as mouthguards, | |
| nightguards, bruxism and TMJ splint appliances, and bite | |
| splints. |
The Thermeo blank is a disc intended for the fabrication of dental
appliances such as mouthguards, nightguards, bruxism and
TMJ splint appliances, and bite splints using CAD/CAM
milling machines. |
| Device Description: | The Thermeo powder/Thermeo liquid is a two-compound
mixable device, containing a powder component and a liquid
component. The device is heat cured for the fabrication of dental
appliances. |
| | The Thermeo blanks are pre-made by pro3dure using the
two-part mixable device. The Thermeo blank is intended to be
used in conjunction with CAD/CAM milling technology
systems. |
| Performance Testing: | Performance testing for the Thermeo System was performed
in accordance with ISO 20795-2 including Flexural
modulus, Flexural Strength, Tensile Strength, and Elongation at
Break. |
| Biocompatibility: | Biocompatibility testing was conducted in accordance with
ISO 10993-1. |
| Shelf-Life: | The shelf life of the Thermeo System is 2 years. Testing
was performed in accordance with ASTM F1980-16. |
4
5
| Subject Device | Predicate Device | Additional Predicate Device | |
|---|---|---|---|
| Device | Thermeo System | Clearsplint ES | |
| (K111828) | Portux CAD/CAM | ||
| Disc (K192153) | |||
| Manufacturer | Pro3dure Medical GmbH | ASTRON DENTAL | |
| CORPORATION | New Stetic S.A. | ||
| Indications for use | Thermeo powder / | ||
| Thermeo liquid is a heat | |||
| cured, moldable, acrylic | |||
| compound system for use | |||
| in the fabrication of dental | |||
| appliances such as | |||
| mouthguards, nightguards, | |||
| bruxism and TMJ splint | |||
| appliances, and bite splints. | |||
| The Thermeo blank is a | |||
| disc intended for the | |||
| fabrication of dental | |||
| appliances such as | |||
| mouthguards, nightguards, | |||
| bruxism and TMJ splint | |||
| appliances, and bite splints | |||
| using CAD/CAM milling | |||
| machines. | Clearsplint ES is a heat | ||
| cured, moldable, acrylic | |||
| compound for use in the | |||
| fabrication of dental | |||
| appliances and dental | |||
| prostheses devices | |||
| including TMJ splint | |||
| appliances, night guards, | |||
| bruxism appliances and | |||
| other devices as prescribed. | For the fabrication of | ||
| crowns, bridges and | |||
| structures for implant | |||
| supported provisional | |||
| removable denture and | |||
| appliance prosthetics. |
- Provisional anterior and
posterior crowns & bridges - Implant and abutment
supported prosthetics. - Partial, complete and
hybrid denture prosthetics
(base and teeth) -
Removable appliances
(splint) |
| Comparison: The indications for the subject and the predicate devices include removable dental
appliances. | | | |
| Chemical Description | Methyl methacrylate-,
BPA- and silicone-free
material | Methyl methacrylate-,
BPA- and silicone-free
material | Polymethylmethacrylate |
| Comparison: The subject and the predicate devices have similar chemical characterization. | | | |
| Manufacturing
Technology | Thermeo powder /
Thermeo liquid: Heat cured
Thermeo blank:
CAD/CAM milling
technology systems. | Clearsplint ES:
Heat cured | CAD/CAM milling
technology systems. |
| Comparison: The subject and the predicate devices fabricate the final product by the same
processes. | | | |
| Product State | Powder Liquid System
Blank | Powder Liquid System | Blank |
| Comparison: The subject and the predicate devices are provided in the same physical states. | | | |
| Performance Testing | ISO 20795-2 | ISO 20795-2 | ISO 20795 |
| Comparison: The subject and the predicate devices comply with the same performance standards. | | | |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 |
| Comparison: The subject and the predicate devices comply with the same biocompatibility standards. | | | |
Comparison to Predicate:
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Conclusion:
The Thermeo System is substantially equivalent in indications, technical characteristics, function, material. Performance, biocompatibility, and shelf life to the predicate device.