NightGuard Flex

K212448 · Sprintray, Inc. · MQC · Nov 12, 2021 · DE

Device Facts

• Record ID: K212448
• Device Name: NightGuard Flex
• Applicant: Sprintray, Inc.
• Product Code: MQC · DE
• Decision Date: Nov 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The SprintRay NightGuard Flex is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

Device Story

NightGuard Flex is a curable dental acrylate resin used to manufacture orthodontic and dental appliances. Input consists of 3D scanned images of a patient's teeth; processed via 3D printer assembly to create the appliance. Curing is performed using a UV lamp. Used in dental offices by trained professionals; clinician trims and cleans the appliance before patient delivery. Output is a custom-fit dental appliance (mouthguard, nightguard, splint, or repositioner). Benefits include patient-specific fit for dental/orthodontic needs.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on 3D-printed samples. Mechanical and chemical performance testing conducted per ISO 20795-1 and -2 standards, evaluating tensile strength, flex strength, impact, hardness, water sorption, solubility, and residual methyl-methacrylate monomers. All results met predefined acceptance criteria.

Technological Characteristics

Material: Curable dental acrylate resin. Principle: Light-based curing of 3D-printed structures. Form factor: Pourable resin for 3D printing. Sterilization: Delivered non-sterile; cleaned by clinician. Standards: ISO 20795-1 and -2 for mechanical/chemical properties.

Indications for Use

Indicated for fabrication of orthodontic and dental appliances including mouthguards, nightguards, splints, and repositioners in a clinical setting by trained dental professionals.

Predicate Devices

• KeySprint's KeySplint Soft (K183598)

Reference Devices

• EnvisonTech's E-Guard (201173)

Submission Summary (Full Text)

{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.

November 12, 2021

SprintRay Inc Sara Moghtadernejad Quality Assurance Speciality 2705 Media Center Drive, Suite 100A Los Angeles, California 90065

Re: K212448

Trade/Device Name: NightGuard Flex Regulatory Class: Unclassified Product Code: MQC, KMY Dated: September 9, 2021 Received: September 10, 2021

Dear Sara Moghtadernejad:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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.

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}------------------------------------------------

510(k) Number (if known)

K212448

Device Name

NightGuard Flex

Indications for Use (Describe)

The SprintRay NightGuard Flex is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

Type of Use (Select one or both, as applicable)

X 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}------------------------------------------------

#### 510(K) SUMMARY VII. K212448

The Company's 510(k) Summary is provided on the following pages.

{4}------------------------------------------------

# 510(k) SUMMARY SprintRay's NightGuard Flex

| Submitter: | SprintRay Inc.<br>2705 Media Center Drive, Suite 100A<br>Los Angeles, CA 90065 |
|-----------------------|--------------------------------------------------------------------------------|
| Phone: | [phone] |
| Contact Person: | Sara Moghtadernejad |
| Date Prepared: | July 05, 2021 |
| Name of Device: | NightGuard Flex |
| Common or Usual Name: | MouthGuard, Prescription |
| Classification Name: | MouthGuard, Prescription |
| Regulatory Class: | Unclassified |
| Product Code: | MQC, KMY |

## Predicate Device

KeySprint's KeySplint Soft (K183598)

#### Reference Device

EnvisonTech's E-Guard (201173)

#### Device Description

The NightGuard Flex consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.

NightGuard Flex is designed to meet appropriate ISO standards for flexibility, sorption and tensile strength to withstand prolonged use in the oral cavity. It is delivered non-sterile and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is

{5}------------------------------------------------

then cleaned, trimmed and verified to fit in the dental office before the patient leaves.

#### Intended Use / Indications for Use

The NightGuard Flex is intended to be used for the manufacture of orthodontic and dental appliances in a clinical setting by trained dental professionals.

The NightGuard Flex is indicated for use in the fabrication of orthodontic and dental appliances such as mouthquards, nightquards, splints and repositioners.

#### Summary of Technological Characteristics

Light-based curing of a 3D printed acrylate resin is the technological principle for both the subject and predicate devices. The NightGuard Flex is poured into a 3D printer, which relies on scanned images of the patient's oral cavity to produce a dental appliance. At a high level, the subject and predicate devices are based on the following same technological elements:

- Are a pourable acrylate resin
- · Are used in conjunction with 3D printers, which rely on common 3D images to define the fabricated dental appliance
- Are cured prior to final trimming and cleaning
- · Are used for the fabrication of orthodontic and dental appliances

The following technological differences exist between the subject and predicate devices:

- · Differences in acrylate resin material
## Performance Data

Biocompatibility testing was performed on samples of the NightGuard Flex that had been formed into dental appliances using a 3D printer.

Additional bench testing based on the test steps laid out in ISO 20795-1 and -2 was performed using dental appliance fabricated from NightGuard Flex. This includes testing to demonstrate that finished NightGuard Flex appliances meet predefined acceptance criteria for tensile strength, flex strength, impact and hardness characteristics, as well as water sorption and solubility, and the presence of residual methyl-methacrylate monomers.

In all instances, the NightGuard Flex functioned as intended and the outcomes were as expected.

{6}------------------------------------------------

# Conclusions

The NightGuard Flex is as safe and effective as its predicate device. The NightGuard Flex has the same intended use and indication, and similar technological characteristics, and principles of operation as its predicate device. The minor technological differences between the NightGuard Flex and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the NightGuard Flex is as safe and effective as the predicate device. Thus, the NightGuard Flex is substantially equivalent.