(90 days)
Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It creates a barrier between upper and lower dentition to protect the patient's overall occlusion.
Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile.
The provided text describes the acceptance criteria and the study that proves the "Night Guard" device meets these criteria. The study focuses on non-clinical performance tests to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Objective of the Test | Reference Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Rigidity | The printed device is rigid enough to stay on the patient's dentition | NA | When fitting the splint onto the master dentition, does it feel sufficiently rigid to stay in place and immobilize the teeth? | Pass |
| Toughness | Printed device is tough enough to withstand breaking | ASTM D695 Compressive Properties | Does the material survive 180 times of flexing cycles? (180 flex cycles is based on a daily insertion of a dry splint for 6 months). Was the maximum compressive stress of the material over 77MPa before break? The material is expected to survive 77MPa of compression stress. | Pass Avg: 159.6 MPa Std Dev: 1.698 |
| Fit | Ensure the device will fit snugly to a patient's dentition and not move. | NA | By visual examination through the splint itself, does the splint seat all the way down onto the occlusal table and/or incisal edge of the metal simulated dentition? Does the splint stay on metal dentition when turned upside down? After applying light pressure to each quadrant of the splint after it is seated on the metal simulated dentition. Does the splint stay in place without another section of the splint separating from the occlusal surfaces or incisal edges of the teeth? Does the splint stay in place without shifting after attempting to rotate the splint back and forth. | Pass |
| Wear Resistance | Devices are sufficiently wear-resistant to withstand teeth wear against the patient's opposing dentition. | ISO 14569 | After 10,000 cycles of abrasion in a 37°C water bath samples must not show signs of cracking or wear to a degree that would jeopardize the efficacy or safety of the device. | Pass |
Additionally, Biocompatibility testing per ISO 10993-1 was passed for cytotoxicity, sensitization, acute systemic toxicity, subacute/subchronic toxicity, genotoxicity, and implantation.
Process Flow validation was performed to ensure that the finished device matches the software output specifications, and the Night Guard met these specifications.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size for each test. However, for the "Toughness" test, the acceptance criteria mention "180 times of flexing cycles," and for "Wear Resistance," it mentions "10,000 cycles of abrasion," indicating the number of iterations or repetitions for these specific tests on material samples. The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective; it appears to be internal testing conducted by 3D Diagnostix Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts or their qualifications for establishing ground truth for the performance tests. The "Rigidity" and "Fit" tests rely on visual examination and manual assessment, but the "expert" status is not defined.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No adjudication method is mentioned for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. This document describes the testing of a physical medical device (night guard), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the subject device is a physical night guard, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance tests (Rigidity, Toughness, Fit, Wear Resistance) is based on compliance with predefined acceptance criteria derived from internal requirements and/or relevant standards (ASTM D695, ISO 14569). It's a combination of objective measurements (e.g., compressive stress for toughness) and subjective assessment against established criteria (e.g., "feels sufficiently rigid," "stays on metal dentition when turned upside down" for fit). For biocompatibility, the ground truth is established by adherence to ISO 10993-1.
8. The sample size for the training set:
This section is not applicable. The Night Guard is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This question is not applicable, as there is no training set for a physical device.
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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
November 25, 2020
3D Diagnostix Inc. Ehab Amin Ouality and Regulatory Consultant 24 Denby Road Allston, Massachusetts 02134
Re: K202465
Trade/Device Name: Night Guard Regulatory Class: Unclassified Product Code: MQC Dated: August 27, 2020 Received: August 27, 2020
Dear Ehab Amin:
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
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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.
for Srinivas "Nandu" Nandkumar, Ph.D. 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: 3D Diagnostix Logo | 3D Diagnostix Inc. |
|---|---|
| Night Guard 510K Traditional File |
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Approved: OMB Form No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement on last page
510(k) Number (if known) K202465
Device Name
Night Guard
Indications for Use (Describe)
Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It creates a barrier between upper and lower dentition to protect the patient's overall occlusion.
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
and a person is not required to respond to, a collection of "An agency may not conduct or sponsor, information unless it displays a currently valid OMB number."
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3D Diaqnostix Inc.
Night Guard 510(K) Summary
510(k) SUMMARY
3D Diagnostix Inc.'s Night Guard 510K Number: K202465
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
[COMPANY'S NAME AND ADDRESS]
3D Diagnostix Inc 24 Denby Road Allston, MA 02134 USA
Phone: 1-617-820-5279 Fax: 1-617-904-1853
Contact Person: Ehab Mahmoud Date Prepared: November 25, 2020
Name of Device and Name/Address of Sponsor
| Name of Device: | Night Guard |
|---|---|
| Common or Usual Name: | Mouthguard, Prescription |
| Classification Name: | Not Applicable |
| Regulatory Class: | Unclassified |
| Product Code: | MQC |
Primary Predicate Devices
Thermoformed Mouthguards/Nightguards K121365 Prismatik Dentalcraft ,Inc. GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP
Intended Use / Indications for Use
The Night Guard is indicated for protection against bruxism and nighttime teeth grinding. it creates a barrier between the upper and lower dentition to protect the patient's overall occlusion.
Technological Characteristics
Based on the comparative analysis of technological characteristics, the Night Guard has the same technological characteristics as the primary predicate device [Thermoformed Mouthguards/Night
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Night Guard 510(K) Summary
Guards], in that all the devices are made from biocompatible material to create a customized- patientspecific Night Guard.
Night guard is substantially equivalent to the Primary Predicate Device [Thermoformed Mouthguards/Night Guards], the two devices are physically the same.
Night Guard is designated to alleviate the pain and damage caused by bruxing or clenching the teeth such as Severe tooth, jaw or facial muscle pains which are common side effects of bruxing or clenching the teeth. Night Guard creates a barrier between upper and lower dentition to protect the patient's overall occlusion the same as the primary Predicate Device [Thermoformed Mouthguards].
Performance Data
As part of demonstrating substantial equivalence of Night Guard to the primary predicate device that are subject to this 510(k) submission, 3D Diagnostix Inc. completed a number of non-clinical performance tests. Night Guard meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inouts and specifications for the device.
Night Guard passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, acute systemic toxicity, Subacute/subchronic toxicity, Genotoxicity, and implantation.
- . Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output, work model and Night Guard were tested and compared. Night Guard met the specifications of this testing.
- . Photopolymer (FormLabs Dental LT Clear V2) is flexible, resilient, tough, and show excellent resistance to environmental stress cracking. The following table summarizes the performed tests and their acceptance criteria and the results.
| TestPerformed | Objective of theTest | ReferenceStandard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Rigidity | The printed deviceis rigid enough tostay on thepatient's dentition | NA. | When fitting the splint onto the masterdentition, does it feel sufficiently rigidto stay in place and immobilize theteeth? | Pass |
| Toughness | Printed device istough enough towithstand breaking | ASTM D695CompressiveProperties of | Does the material survive 180 times offlexing cycles? (180 flex cycles isbased on a daily insertion of a drysplint for 6 months). | Pass |
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Night Guard 510(K) Summary
| TestPerformed | Objective of theTest | ReferenceStandard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Rigid Plastics | Was the maximum compressive stress of the material over 77MPa before break? The material is expected to survive 77MPa of compression stress | Pass Avg:159.6MPa Std Dev:1.698 | ||
| Fit | Ensure the devicewill fit snugly to apatient's dentitionand not move. | NA. | By visual examination through the splint itself, does the splint seat all the way down onto the occlusal table and/or incisal edge of the metal simulated dentition? Does the splint stay on metal dentition when turned upside down? After applying light pressure to each quadrant of the splint after it is seated on the metal simulated dentition. Does the splint stay in place without another section of the splint separating from the occlusal surfaces or incisal edges of the teeth? Does the splint stay in place without shifting after attempting to rotate the splint back and forth | Pass |
| WearResistance | Devicesaresufficientlywear-resistanttowithstandteethwear against thepatient's opposingdentition. | ISO 14569 | After 10,000 cycles of abrasion in a 37C water bath samples must not showsigns of cracking or wear to a degreethat would jeopardize the efficacy orsafety of the device | Pass |
In all instances, the Night Guard functioned as intended and Biocompatibility Testing, Process Flow Validation, and Material Testing observed was as expected.
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Night Guard 510(K) Summary
Substantial Equivalence
| Feature | Proposed DeviceNight Guard | Predicate DeviceThermoformedMouthguards/Nightguards |
|---|---|---|
| K Number | K202465 | K121365 |
| Manufacturer | 3D Diganostix Inc. | Prismatik Dentalcraft, Inc.GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP |
| RegulationNumber | Not Applicable | 21 CFR 807.92 |
| DeviceClassificationName | Mouthguard, Prescription | Mouthguard, Prescription |
| Product Code | MQC | MQC |
| Device Class | Unclassified | Class II |
| Indications forUse | Night Guard is indicated for theprotection against bruxism andnighttime teeth grinding. It creates abarrier between upper and lowerdentition to protect the patient'soverall occlusion. | The ThermoformedMouthguards/Nightguards areintended for protection againstbruxism and nighttime teeth grinding.They create a barrier between theupper and lower dentition to protectthe patient's overall occlusion. |
| Device Description | Night Guards are designated toalleviate the pain and damagecaused by bruxing or clenching theteeth. Severe tooth, jaw or facialmuscle pains are common sideeffects of bruxing or clenching theteeth. These patients specific devicesfit over upper or lower teeth duringsleep and can offset the effects ofbruxing or clenching, while protectingteeth from daily wear and tear. NightGuard is shipped non-sterile. | The ThermoformedMouthguards/Nightguards aredesigned to alleviate the painand damage caused by bruxing orclenching of the teeth. Severe tooth,jaw or facial muscle pains arecommon side effects of bruxing orclenching of the teeth.These patients specific devices fitover upper or lower teeth during sleepand can offset the effects of bruxingor clenching, while protecting teethfrom daily wear and tear. Night Guardis shipped non-sterile. |
| Mode ofAction | They create a barrier between theupperand lower dentition to protect thepatient's overall occlusion. | They create a barrier between theupperand lower dentition to protect thepatient's overall occlusion. |
| Anatomy Location | Mouth; mucosal | Mouth; mucosal |
| Size | Patient specific | Patient specific |
| ManufacturingMethod | 3D Printing | Thermoforming |
| Feature | Proposed DeviceNight Guard | Predicate DeviceThermoformedMouthguards/Nightguards |
| K Number | K202465 | K121365 |
| Material | Photopolymer Resin | Thermoplastic Polymer |
| MaterialProperties | Dental LT Clear V2 (BiocompatiblePhotopolymer Resin) | Approved Biocompatible material Co-polyester (Erkoflex)Polyurethane (Erkodur)Ethyl vinyl acetate (EVA)(Erkolog-Pro) |
| Design | Pre-formed Device | Pre-formed Device |
| OTC/PrescriptionDevice | Prescription use | Prescription use |
| Reusable Device | Yes/Single consumer /Patient | Yes/Single consumer /Patient |
| Sterility | Non-Sterile | Non-Sterile |
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3D Diaqnostix Inc.
Night Guard 510(K) Summary
The Night Guard and Thermoformed Mouthguards have the same intended use and similar indications, technological characteristics and principles of operation. The technological differences between the 3D Diagnostix's Night Guard and Thermoformed Mouthguards/Nightguards are: 1. Night Guard manufactured by 3D Printing method.
-
- Material used for Night Guard manufacturing by using 3D Printing Method.
These differences do not present any new issues because they do not impact on intended uses, indications, and principles of operation. Thus, the Night Guard is substantially equivalent to the Thermoformed Mouthguards/Nightguards.
- Material used for Night Guard manufacturing by using 3D Printing Method.
3D Diagnostix Inc. has relied on the existing predicated devices for substantial equivalence of its Night Guard device. In addition, the biocompatibility of the materials is confirmed according to ISO 10993-1. Therefore, the Night Guard is substantial equivalent for its intended use.
Conclusions
As demonstrated in this application, the proposed device Night Guard, has the same intended use as the identified predicate device. Thermoformed Mouthquards originally cleared under premarket notification K121365, and employs the same basic technological characteristics; any differences between the proposed device and the predicate are minor and do not constitute different technological characteristics. The relevant information on biocompatibility and the performance testing confirm the Night Guard fulfills its intended use as substantially equivalent to a legally marketed predicate device. The Night Guard is therefore substantially equivalent to the cited predicate.
N/A