KeyPrint KeySplint Soft

K183598 · Keystone Industries · MQC · Nov 15, 2019 · DE

Device Facts

• Record ID: K183598
• Device Name: KeyPrint KeySplint Soft
• Applicant: Keystone Industries
• Product Code: MQC · DE
• Decision Date: Nov 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

Device Story

KeyPrint KeySplint Soft is a photopolymer resin used for the additive manufacturing (3D printing) of dental appliances; specifically mouthguards, nightguards, splints, and repositioners. The material is processed via light-curing 3D printing systems. The final printed appliance is intended for use by dental professionals to provide therapeutic or protective dental functions for patients. The device is used in a dental laboratory or clinical setting. The healthcare provider uses the printed appliance to manage patient dental conditions, such as bruxism or malocclusion, by providing a custom-fitted, flexible intraoral device.

Clinical Evidence

Bench testing only.

Technological Characteristics

Photopolymer resin for additive manufacturing (3D printing). Material is designed for dental appliance fabrication. The device is a chemical material used in conjunction with light-curing 3D printing hardware.

Indications for Use

Indicated for the fabrication of orthodontic and dental appliances including mouthguards, nightguards, splints, and repositioners. Prescription use only.

Submission Summary (Full Text)

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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.

November 15, 2019

Keystone Industries Negar Movahed Director of Product Development 480 S. Democrat Rd Gibbstown, New Jersey 08027

Re: K183598

Trade/Device Name: KeyPrint KeySplint Soft Regulatory Class: Unclassified Product Code: MQC, KMY Dated: October 11, 2019 Received: October 15, 2019

Dear Negar Movahed:

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 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,

for Srinivas Nandkumar, Ph.D. Acting 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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Image /page/2/Picture/0 description: The image shows the logo for Keystone Industries. The word "keystone" is written in a simple, sans-serif font, with the "o" replaced by a purple, star-shaped design. Below the word "keystone" is the word "industries" in a smaller, sans-serif font.

## Section 5

## Indications for Use

510(k) Number (if known): K183598

Device Name: KeyPrint® KeySplint Soft™

## Indications for Use:

The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

Prescription Use X__AND/OR Over-The-Counter Use __

(Part 21 CFR 801 Subpart D)(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Replaces page 4 of submission