Serena Sleep Night Guard

K230495 · Meris Investment Group · MQC · Oct 13, 2023 · DE

Device Facts

• Record ID: K230495
• Device Name: Serena Sleep Night Guard
• Applicant: Meris Investment Group
• Product Code: MQC · DE
• Decision Date: Oct 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains.

Device Story

Custom-made intraoral appliance; fabricated via CAD/CAM from patient dental model or STL file. Device functions via disocclusion mechanism to protect teeth/restorations from bruxism forces and alleviate TMJ/jaw/muscle/headache pain. Used by adult patients; prescribed by clinicians. Non-sterile; single-patient, multiple-use. Benefits include reduction of dental damage and pain associated with parafunctional activity.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including durability, manufacturing validation, and adherence to ISO 20795-2:2013 standards (flexural strength, flexural modulus, polishability, water sorption, water solubility, color, porosity, fracture toughness, max stress intensity, and total fracture work).

Technological Characteristics

Material: Polyamide 12 (PA 2200). Manufacturing: CAD/CAM. Form factor: Custom-fitted removable intraoral appliance. Mechanism: Disocclusion. Sterility: Non-sterile. Standards: ISO 20795-2:2013 (Dentistry - Base Polymers - Part 2: Orthodontic Base Polymers).

Indications for Use

Indicated for adult patients requiring protection of teeth and restorations from bruxism forces and alleviation of temporomandibular joint, jaw, muscle, and tension headache pains.

Predicate Devices

• Panthera Occlusal Appliance (K203596)

Reference Devices

• Serena Sleep BMA/EMA (K203606)
• Panthera Anti-Snoring Device (K143244)

Submission Summary (Full Text)

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October 13, 2023

Meris Investment Group % Janice Farris Regulatory Affairs Consultant Prime Path Medtech 811 Lakeview Dr. Shoreview, Minnesota 55126

Re: K230495

Trade/Device Name: Serena Sleep Night Guard Regulatory Class: Unclassified Product Code: MQC, OCO Dated: September 14, 2023 Received: September 14, 2023

Dear Janice Farris:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., COIA 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

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Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K230495

Device Name Serena Sleep Night Guard

Indications for Use (Describe)

The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate tomporomandibular joint, jaw, and muscle and tension headache pains.

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

| <span style="font-size:120%;">✓</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:120%;">❍</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### Section 5. 510(k) Summary K230495

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| Submitter: | Serena Sleep | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--|
| Company Contact Person:<br>Phone:<br>Email: | Gary Maas, President<br>98 St. Croix Trail N PO Box 98 Lakeland, MN 55043<br>[phone]<br>[e-mail] | |
| Submission<br>Correspondent: | Janice Farris, Regulatory Affairs Consultant | |
| Address:<br>Phone: | 811 Lakeview Dr. Shoreview, MN 55126<br>[phone] | |
| Email: | [e-mail] | |
| Date Prepared: | September 12, 2023 | |
| Proprietary Name: | Serena Sleep Night Guard | |
| Common Name: | Mouthguard, Prescription | |
| Product Code: | MQC | |
| Subsequent Product<br>Code: | OCO | |
| Device Classification: | Unclassified | |
| Predicate Device: | Panthera Occlusal Appliance (K203596) | |

### Device Description:

The Serena Sleep Night Guard/Occlusal Appliance is a custom-made intraoral device used for protecting teeth and restorations against the forces of bruxism and alleviating temporomandibular joint, jaw, and muscle and tension headache pains.

### Indications for Use:

The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains

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| Specification | Serena Sleep Night Guard | Panthera Occlusal<br>(Predicate Device) | Comparison Result |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| 510(k) Number | K230495 | K203596 | |
| Device Photo | Image: Serena Sleep Night Guard | Image: Panthera Occlusal | |
| Indication for Use | The Serena Sleep Night<br>Guard/Occlusal Appliance is a<br>removable medical device<br>that is fitted to the patient's<br>mouth and is intended to<br>protect teeth and<br>restorations against the<br>forces of bruxism and<br>alleviate temporomandibular<br>joint, jaw, and muscle and<br>tension headache pains. | The Panthera Occlusal<br>Appliance is indicated for<br>protection of teeth and<br>restorations from the forces<br>and damage of<br>parafunctions like bruxism,<br>prevention of noise<br>associated with bruxism, and<br>for alleviation of<br>temporomandibular joint,<br>muscle and tension<br>headache pains associated<br>with temporomandibular<br>disorders | Equivalent |
| Product Code | MQC, OCO | MQC, OCO | Equivalent |
| Class | Unclassified | Unclassified | Equivalent |
| Mechanism of<br>Action | Disocclusion | Disocclusion | Equivalent |
| Use of Device | Removable intraoral device. Single<br>patient multiple use. Prescription<br>use only. | Removable intraoral device.<br>Single patient multiple use.<br>Prescription use only. | Equivalent |
| Target Population | Adult patients | Adult patients | Equivalent |
| Design | Computer-aided design<br>(CAD) from patient dental<br>model or stl file | Computer-aided design<br>(CAD) from patient dental<br>model or stl file | Equivalent |
| Materials | Polyamide 12 (PA 2200) | Made from polymers<br>(polyamide type 12), metal-<br>free | Equivalent |
| Manufacturing | Computer-aided<br>manufacturing (CAM) | Computer-aided<br>manufacturing (CAM) | Equivalent |
| Supplied<br>Sterile/Non-Sterile | Non-sterile | Non-sterile | Equivalent |
| Biocompatibility:<br>ISO 10993-5 | Not performed as the<br>materials are identical to<br>Serena Sleep BMA/EMA<br>(K203606) | Not performed as the<br>materials are identical to<br>Panthera Anti-Snoring<br>Device (K143244) | Equivalent |

# Comparison to Predicate Device: Night Guard

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## Non-Clinical Performance Testing (Bench)

The bench testing includes assessment of the physical properties of the Serena Sleep Night Guard/Occlusal Appliance and its ability to achieve its intended use. The submission includes durability testing, manufacturing validation, and testing to the recognized standard ISO 20795-2:2013 Dentistry - Base Polymers - Part 2: Orthodontic Base Polymers (flexural strength, flexural modulus, polishability, water sorption, water solubility, color, freedom from porosity, fracture toughness, max stress intensity factor, and total fracture work).

### Clinical Performance Testing

The technological characteristics, indications for use, material, and manufacturing processes are the same or similar to the predicate device and therefore, no Clinical Testing were deemed necessary to demonstrate the safety and effectiveness of the subject device.

### Statement of Equivalence

Based on comparison of indications for use, user population, method of manufacturing, non-clinical performance testing, mechanical and technological features, the Serena Sleep Night Guard/Occlusal Appliance has been shown to be substantially equivalent to the legally marketed predicate device. This device does not raise any new safety or effectiveness questions as compared to the predicate device.