(132 days)
No
The description focuses on the physical properties and function of a custom-fit intraoral device, with no mention of AI or ML capabilities.
Yes
The device is indicated for protecting against forces and damage from parafunctions, preventing noise associated with bruxism, and alleviating pain related to temporomandibular disorders, which are all therapeutic uses.
No
The device is an "Occlusal Appliance" indicated for protection against and alleviation of symptoms related to bruxism and temporomandibular disorders, acting as a "protective barrier" rather than providing a diagnosis.
No
The device description clearly states it is a "removable intraoral device" and a "patient-specific splint," indicating it is a physical, hardware-based medical device.
Based on the provided information, the Panthera Occlusal Appliance is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Panthera Occlusal Appliance clearly states it is a removable intraoral device that fits over the teeth. It acts as a physical barrier and is worn by the patient. It does not involve the analysis of any biological samples (like blood, urine, tissue, etc.).
- The intended use is for protection from physical forces and alleviation of pain. The indications for use and device description focus on the mechanical function of the appliance in preventing damage from bruxism and reducing associated pain. This is a physical intervention, not a diagnostic test.
Therefore, the Panthera Occlusal Appliance falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Panthera Occlusal Appliance is indicated for protections from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.
Product codes
MQC, OCO
Device Description
The Panthera Occlusal Appliance is a removable intraoral device used for protecting teeth and restorations against the forces of bruxism. It consists of patient-specific splint that fit over the upper or lower teeth. This device functions as a protective barrier for teeth and restorations by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (like grinding and clenching) and alleviating temporomandibular joint, jaw, and muscle and tension headache pains. There are various occlusal designs for this application, all with varying degrees of function and suitability depending on the patient's needs. The Panthera Occlusal Appliance is customized for each patient based on the clinician's prescription, and is to be worn every day during hours of sleep.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral / teeth
Indicated Patient Age Range
Adult patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing includes assessment of the physical properties and ability to achieve intended use, meeting the same specifications as the primary predicate.
Biocompatibility testing from reference device (K143244) is valid for the proposed device due to identical material composition and manufacturing. Risk analysis per ISO 14971 found no new concerns.
Human clinical study was not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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, there is a symbol representing the Department of Health & Human Services. To the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's role in protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
April 20, 2021
Martine Fortin, Director Regulatory Affairs and Quality Assurance Panthera Dental Inc. 9105, rue John-Simons Quebec, Quebec G2B OS6 Canada
Re: K203596
Trade/Device Name: Panthera Occlusal Appliance Regulatory Class: Unclassified Product Code: MQC, OCO Dated: March 19, 2021 Received: March 22, 2021
Dear Martine Fortin:
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.
Michael E. Adiodha. 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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Indications for Use
510(k) Number (if known) K203596
Device Name Panthera Occlusal Appliance
Indications for Use (Describe)
The Panthera Occlusal Appliance is indicated for protections from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a logo for a dental practice. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL" in purple font. The word "PANTHERA" is in a larger font than the word "DENTAL". The panther is the main focus of the logo, and it is positioned to look sleek and powerful.
510 (k) Summary
Owner Information 1.
| Owner's name | Panthera Dental Inc. |
|---|---|
| Owner's address | 9105 rue John-Simons |
| Québec (QC) G2B 0S6 | |
| Canada | |
| Telephone | (418) 527-0388 |
| Fax | (418) 431-9942 |
| Official Contact | Martine Fortin |
| Director, Quality Assurance and Regulatory Affairs | |
| regulatory@panthera.com | |
| Date Prepared | April 19, 2021 |
Device Name 2.
| Trade Name | Panthera Occlusal Appliance |
|---|---|
| Common Name | Mouthguard, Prescription |
| Classification | Unclassified, Pre-Amendment |
| Review Panel | Dental |
| Product Code | MQC |
| Subsequent Product Code | OCO |
| 510(k) number | K203596 |
3. Predicate devices
| Primary Predicate | The POD (K182820) |
|---|---|
| Reference Devices | SomnoBrux - Various versions of SomnoBrux (K102909) |
| Panthera Anti-Snoring Device (K143244) |
4. Description
The Panthera Occlusal Appliance is a removable intraoral device used for protecting teeth and restorations against the forces of bruxism. It consists of patient-specific splint that fit over the upper or lower teeth. This device functions as a protective barrier for teeth and restorations by creating physical separation between upper and lower tooth surfaces
4
Image /page/4/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther, the word "PANTHERA" is written in a bold, sans-serif font, with a purple line underneath. Below "PANTHERA", the word "DENTAL" is written in a smaller, sans-serif font.
preventing tooth damage caused by bruxism (like grinding and clenching) and alleviating temporomandibular joint, jaw, and muscle and tension headache pains. There are various occlusal designs for this application, all with varying degrees of function and suitability depending on the patient's needs. The Panthera Occlusal Appliance is customized for each patient based on the clinician's prescription, and is to be worn every day during hours of sleep.
5. Indications for Use
The Panthera Occlusal Appliance is indicated for protection of teeth and restorations from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.
Technological characteristics 6.
The technical characteristics of the Panthera Occlusal Appliance are substantially equivalent to the three (3) previously marketed devices. The table below compares the technological aspects of the new, the predicate, and the references devices.
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Image /page/5/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a stalking pose above the words "PANTHERA DENTAL" in a stylized font. The word "PANTHERA" is in a larger, purple font, while "DENTAL" is in a smaller, gray font below it.
| Feature | Panthera Occlusal
Appliance
(proposed device) | The POD
(Primary Predicate)
K182820 | SomnoBrux Splint
(Reference device)
K102909 | The Panthera Anti-
Snoring Device
(Reference device)
K143244 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Classification | Unclassified | Same | Same | N/Ap. |
| Product code | MQC, OCO | Same | MQC | N/Ap. |
| Indications for
Use | The Panthera Occlusal
Appliance is indicated
for protection of teeth
and restorations from
the forces and damage
of parafunctions like
bruxism, prevention of
noise associated with
bruxism, and for
alleviation of
temporomandibular
joint, muscle and
tension headache pains
associated with
temporomandibular
disorders. | For the amelioration of
clenching and bruxing
associated
with TMD and is to
be used to aid in the relief
of symptoms of
TMD/TMJ. | Used for the protection of
teeth and restorations
from the forces of
bruxism | N/Ap. |
| Materials of
construction | Made from polymers
(polyamide type 12),
metal-free | Methyl
methacrylate,
medical grade
stainless steel | Acrylic | Same |
| Prescription/
OTC | Prescription only | Same | Same | Same |
Table 1: Comparison chart between the submitted device and the predicates.
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Image /page/6/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its head lowered and its tail curled up. Below the panther, the word "PANTHERA" is written in a stylized font, with the word "DENTAL" written in a smaller font below it. The word "PANTHERA" is purple.
Traditional 510(k) – Panthera Occlusal Appliance
| Feature | Panthera Occlusal
Appliance
(proposed device) | The POD
(Primary Predicate)
K182820 | SomnoBrux Splint
(Reference device)
K102909 | The Panthera Anti-
Snoring Device
(Reference device)
K143244 |
|------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Fixed/
removable | Removable | Same | Same | Same |
| Supplied
sterile/non
sterile | Non sterile | Same | Same | Same |
| Target
population | Adult patients | Same | Same | Same |
| Single Use/
reusable | Reusable | Same | Same | Same |
| Design | Computer-aided
design (CAD) from
patient dental model or
stl file | Custom-designed from
patient dental model by
dental technicians | Custom-designed from
patient dental model by
dental technicians | Same |
| Manufacturing | Computer-aided
manufacturing (CAM) | N/Ap. | N/Ap. | Same |
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Image /page/7/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL". The word "PANTHERA" is in a stylized font, and the word "DENTAL" is in a smaller, simpler font. A purple line is underneath the word "PANTHERA".
Non-clinical performance data 7.
Bench testing
The bench testing includes assessment of the physical properties of the Panthera Occlusal Appliance and its ability to achieve its intended use. The Panthera Occlusal Appliance meets the same specifications as set for the primary predicate.
Biocompatibility testing
The biocompatibility testing conducted for the reference device (K143244) is valid because the final product of the proposed device (including material composition and manufacturing) is the same as the final product of the reference device (K143244). Therefore, no additional biocompatibility testing was conducted.
In addition, a risk analysis was performed as per ISO 14971, and found no new concerns for the subject device.
8. Clinical performance data
Human clinical study was not deemed necessary to support substantial equivalence. The Panthera Occlusal Appliance does not use design dissimilar from the primary predicate and reference devices, does not use new technologies different from the primary predicate and reference devices, and does not deviate from the indications for use of the primary predicate and reference devices.
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Image /page/8/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther, the word "PANTHERA" is written in a bold, sans-serif font, with the word "DENTAL" written in a smaller font to the right.
Substantial Equivalence Conclusion 9.
The new device, the Panthera Occlusal Appliance, is considered substantially equivalent to the predicate and the reference devices. The POA has the same indications for use as the predicate device (K182820); it is indicated for the same user population as the predicate and the reference devices; it uses biocompatible material for the manufacturing, as the reference device (K143244) does, and it has equivalent technological characteristics as the ones for the predicate and the reference devices.