← Product Code MQC · K212017 # Thermeo System (K212017) _Pro3Dure Medical GmbH · MQC · Apr 8, 2022 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K212017 ## Device Facts - **Applicant:** Pro3Dure Medical GmbH - **Product Code:** MQC - **Decision Date:** Apr 8, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended 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. ## Device Story Thermeo System comprises two-part mixable powder/liquid acrylic compound and pre-made blanks; used for fabrication of dental appliances (mouthguards, nightguards, bruxism/TMJ splints, bite splints). Powder/liquid system is heat-cured; blanks are processed via CAD/CAM milling machines. Used in dental laboratory settings by technicians. Final appliances provide therapeutic benefit for bruxism and TMJ management. System is methyl methacrylate-, BPA-, and silicone-free. ## Clinical Evidence No clinical data. Bench testing only. Performance testing conducted per ISO 20795-2 (flexural modulus, flexural strength, tensile strength, elongation at break). Biocompatibility testing per ISO 10993-1. Shelf-life testing per ASTM F1980-16. ## Technological Characteristics Acrylic compound system (powder/liquid) and CAD/CAM discs. Methyl methacrylate-, BPA-, and silicone-free. Heat-cured. Complies with ISO 20795-2 for mechanical properties and ISO 10993 for biocompatibility. Shelf life 2 years (ASTM F1980-16). ## Predicate Devices - Astron Dental Clearsplint ES ([K111828](/device/K111828.md)) - New Stetic S.A. Portux CAD/CAM Disc ([K192153](/device/K192153.md)) ## Reference Devices - Pro3dure GR-17 Resin System ([K201827](/device/K201827.md)) - Pro3dure GR Splint Resin System ([K211415](/device/K211415.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: {6}------------------------------------------------ ## Conclusion: The Thermeo System is substantially equivalent in indications, technical characteristics, function, material. Performance, biocompatibility, and shelf life to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K212017](https://fda.innolitics.com/device/K212017) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com