(99 days)
201173
No
The description focuses on the material properties and the 3D printing process, with no mention of AI or ML for image processing, design, or any other function.
No.
The device is a resin used to fabricate orthodontic and dental appliances, rather than being a therapeutic device itself. These appliances (like nightguards and splints) can have a therapeutic effect, but the 'NightGuard Flex' is the material for their creation.
No
The device is a material (curable dental acrylate resin) used in conjunction with a 3D printer to fabricate orthodontic and dental appliances. It does not perform any diagnostic function.
No
The device description clearly states it consists of a curable dental acrylate resin and is a material used in conjunction with a 3D printer to manufacture a physical dental appliance. This is a hardware component (the resin material itself) and a manufacturing process involving hardware (3D printing and UV curing).
Based on the provided information, the SprintRay NightGuard Flex is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- SprintRay NightGuard Flex Function: The SprintRay NightGuard Flex is a material used to fabricate physical dental appliances (mouthguards, nightguards, etc.) based on a 3D scan of a patient's teeth. It is a manufacturing material, not a diagnostic test performed on a biological sample.
- Intended Use: The intended use clearly states fabrication of orthodontic and dental appliances, not diagnosis or detection of any condition.
- Device Description: The description focuses on the material properties and the manufacturing process of the dental appliance.
- Performance Studies: The performance studies described are bench testing on the fabricated appliance's physical properties and biocompatibility, not diagnostic performance metrics like sensitivity or specificity.
In summary, the SprintRay NightGuard Flex is a material used in the manufacturing of a medical device (the dental appliance), but it is not an in vitro diagnostic device itself.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
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 then cleaned, trimmed and verified to fit in the dental office before the patient leaves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professionals, clinical setting, dental office
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KeySprint's KeySplint Soft (K183598)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
EnvisonTech's E-Guard (201173)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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 (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
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510(k) Number (if known)
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)
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510(K) SUMMARY VII. K212448
The Company's 510(k) Summary is provided on the following pages.
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510(k) SUMMARY SprintRay's NightGuard Flex
| Submitter: | SprintRay Inc.
2705 Media Center Drive, Suite 100A
Los Angeles, CA 90065 |
|-----------------------|--------------------------------------------------------------------------------|
| Phone: | (800) 914-8004 |
| 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.