(90 days)
No
The summary describes a physical dental device for bruxism and does not mention any AI/ML components or capabilities.
Yes.
The device is intended to alleviate pain and damage caused by bruxing or clenching, and it creates a barrier to protect the patient's overall occlusion, which are therapeutic actions.
No
The device description indicates it alleviates pain and damage caused by bruxing or clenching, and protects teeth; it does not mention diagnosing or identifying conditions.
No
The device description clearly states that the device is a physical "Night Guard" that fits over teeth and is shipped non-sterile. The performance studies also focus on biocompatibility and physical properties of the material, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for protection against bruxism and nighttime teeth grinding by creating a physical barrier. This is a mechanical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and function of the device in alleviating pain and protecting teeth. It does not mention any diagnostic capabilities or analysis of biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
MQC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth; mucosal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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 table summarizes the performed tests and their acceptance criteria and the results:
- Rigidity: Objective - The printed device is rigid enough to stay on the patient's dentition. Acceptance Criteria - When fitting the splint onto the master dentition, does it feel sufficiently rigid to stay in place and immobilize the teeth? Results - Pass.
- Toughness: Objective - Printed device is tough enough to withstand breaking. Reference Standard - ASTM D695 Compressive Properties of Rigid Plastics. Acceptance Criteria - 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. Results - Pass, Avg: 159.6 MPa, Std Dev: 1.698.
- Fit: Objective - Ensure the device will fit snugly to a patient's dentition and not move. Acceptance Criteria - 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. Results - Pass.
- Wear Resistance: Objective - Devices are sufficiently wear-resistant to withstand teeth wear against the patient's opposing dentition. Reference Standard - ISO 14569. Acceptance Criteria - 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. Results - Pass.
In all instances, the Night Guard functioned as intended and Biocompatibility Testing, Process Flow Validation, and Material Testing observed was as expected.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
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.
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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Image /page/4/Picture/0 description: The image shows the logo for 3D Diagnostix. The logo has the text "3D" in blue, followed by a vertical line, and then the text "Diagnostix" in orange. Below the word "Diagnostix" is the text ".COM".
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.
| 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 of | 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). | Pass |
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Image /page/5/Picture/0 description: The image shows the logo for 3D Diagnostix. The logo has the text "3D Diagnostix" in a sans-serif font. The "3D" is in blue, and the "Diagnostix" is in a light orange color. Below the word "Diagnostix" is the text ".COM" in a smaller font.
Night Guard 510(K) Summary
| Test
Performed | Objective of the
Test | Reference
Standard | 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:
159.6
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 |
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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Image /page/6/Picture/0 description: The image shows the logo for 3D Diagnostix. The logo has the number 30 in blue on the left, followed by a vertical line. To the right of the line is the word "Diagnostix" in orange, with ".COM" in a smaller font below it.
Night Guard 510(K) Summary
Substantial Equivalence
| Feature | Proposed Device
Night Guard | Predicate Device
Thermoformed
Mouthguards/Nightguards |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K202465 | K121365 |
| Manufacturer | 3D Diganostix Inc. | Prismatik Dentalcraft, Inc.
GLIDEWELL LABORATORIES-
SLEEP DEVICES GROUP |
| Regulation
Number | Not Applicable | 21 CFR 807.92 |
| Device
Classification
Name | Mouthguard, Prescription | Mouthguard, Prescription |
| Product Code | MQC | MQC |
| Device Class | Unclassified | Class II |
| Indications for
Use | Night Guard is indicated for the
protection against bruxism and
nighttime teeth grinding. It creates a
barrier between upper and lower
dentition to protect the patient's
overall occlusion. | The Thermoformed
Mouthguards/Nightguards are
intended for protection against
bruxism and nighttime teeth grinding.
They create a barrier between the
upper and lower dentition to protect
the patient's overall occlusion. |
| Device Description | 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 Thermoformed
Mouthguards/Nightguards are
designed to alleviate the pain
and damage caused by bruxing or
clenching of the teeth. Severe tooth,
jaw or facial muscle pains are
common side effects of bruxing or
clenching of 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. |
| Mode of
Action | They create a barrier between the
upper
and lower dentition to protect the
patient's overall occlusion. | They create a barrier between the
upper
and lower dentition to protect the
patient's overall occlusion. |
| Anatomy Location | Mouth; mucosal | Mouth; mucosal |
| Size | Patient specific | Patient specific |
| Manufacturing
Method | 3D Printing | Thermoforming |
| Feature | Proposed Device
Night Guard | Predicate Device
Thermoformed
Mouthguards/Nightguards |
| K Number | K202465 | K121365 |
| Material | Photopolymer Resin | Thermoplastic Polymer |
| Material
Properties | Dental LT Clear V2 (Biocompatible
Photopolymer Resin) | Approved Biocompatible material Co-
polyester (Erkoflex)
Polyurethane (Erkodur)
Ethyl vinyl acetate (EVA)(Erkolog-
Pro) |
| Design | Pre-formed Device | Pre-formed Device |
| OTC/Prescription
Device | Prescription use | Prescription use |
| Reusable Device | Yes/Single consumer /Patient | Yes/Single consumer /Patient |
| Sterility | Non-Sterile | Non-Sterile |
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Image /page/7/Picture/0 description: The image shows the logo for 3D Diagnostix. The logo is split into two parts, with "3D" in a bold, blue font on the left, followed by a vertical line. To the right of the line, "Diagnostix" is written in a lighter, orange color, with ".COM" in a smaller font below it.
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.