dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S

K222604 · Dentona AG · MQC · Apr 21, 2023 · DE

Device Facts

• Record ID: K222604
• Device Name: dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
• Applicant: Dentona AG
• Product Code: MQC · DE
• Decision Date: Apr 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Dentona vivatemp and Dentona flexisplint (powder/liquid) are heat cured, moldable, acrylic compound systems for use in the fabrication of dental appliances such as splints, night guards, mouthquards and bruxism appliances. The optimill memosplint blank and the optimill memosplint version S blank are discs intended for the fabrication of dental appliances such as splints, night guards and bruxism appliances using CAD/CAM milling machines.

Device Story

Device family includes heat-cured acrylic powder/liquid systems (dentona vivatemp, dentona flexisplint) and CAD/CAM milling discs (optimill memosplint, optimill memosplint version S). Acrylic systems are manually molded and heat-cured to form dental appliances. Milling discs are processed via CAD/CAM milling machines to fabricate appliances. Used in dental clinics or laboratories by dental professionals. Final appliances (splints, night guards, mouthguards) are worn by patients to manage bruxism or protect teeth. Benefits include customized fit for patient dental anatomy and protection against tooth wear/grinding.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Acrylic-based materials for heat-cured manual fabrication and CAD/CAM milling discs. No electronic components, software, or energy sources integral to the device function.

Indications for Use

Indicated for fabrication of dental appliances including splints, night guards, mouthguards, and bruxism appliances for patients requiring such devices.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".

April 21, 2023

dentona AG % Andreas Foerster Owner APF Consulting Kleikstrasse 78 Herzogenrath, North-Rhine Westphalia 52134 Germany

Re: K222604

Trade/Device Name: dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S Regulatory Class: Unclassified Product Code: MQC Dated: March 21, 2023 Received: March 21, 2023

Dear Andreas Foerster:

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., 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

{2}------------------------------------------------

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

#### K222604

Device Name

dentona flexisplint:

optimill memosplint;

dentona vivatemp;

optimill memosplint version S

Indications for Use (Describe)

Dentona vivatemp and Dentona flexisplint (powder/liquid) are heat cured, moldable, acrylic compound systems for use in the fabrication of dental appliances such as splints, night guards, mouthquards and bruxism appliances.

The optimill memosplint blank and the optimill memosplint version S blank are discs intended for the fabrication of dental appliances such as splints, night guards and bruxism appliances 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."