The Panthera Anti-Snoring X3 Device

K171576 · Panthera Dental, Inc. · LRK · Feb 22, 2018 · Dental

Device Facts

• Record ID: K171576
• Device Name: The Panthera Anti-Snoring X3 Device
• Applicant: Panthera Dental, Inc.
• Product Code: LRK · Dental
• Decision Date: Feb 22, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Device Story

The Panthera Anti-Snoring X3 Device is a custom-fit, removable intraoral mandibular repositioning device. It consists of two splints (upper and lower) fabricated via CAD/CAM and selective laser sintering. The device functions by maintaining the mandible in a forward position during sleep, which increases pharyngeal space to improve airflow. It is a push-based system featuring an adjustable clip assembly on the maxillary splint; the dentist or physician adjusts the clip length to set the degree of mandibular advancement (up to 5 mm in 1 mm increments). The device is used by patients at home during sleep. By mechanically repositioning the jaw, the device helps alleviate snoring and mild to moderate OSA, potentially improving patient sleep quality.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility assessments (ISO 10993-1, -5, -10), fatigue testing of the stop-clip assembly, and 3D printing build location validation (ASTM D638, NISTIR 8059).

Technological Characteristics

Materials: Polyamide type 12 (biocompatible polymer). Fabrication: CAD/CAM and selective laser sintering. Design: Two-piece custom splint system with adjustable clip-based mandibular advancement mechanism. Dimensions: Up to 5 mm advancement, up to 6 mm vertical opening. Connectivity: None. Sterilization: Non-sterile.

Indications for Use

Indicated for adult patients with snoring and mild to moderate obstructive sleep apnea (OSA).

Regulatory Classification

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Predicate Devices

• The Panthera Anti-Snoring Device (K143244)

Reference Devices

• SomnoDent Flex™ (K073004)
• DynaFlex Anti-Snoring & Sleep Apnea Devices (K103076)
• MicrO2 Obstructive Sleep Apnea Device (K133683)

Submission Summary (Full Text)

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Panthera Dental Inc. Martine Fortin Regulatory Affairs and Quality Assurance Director 2035. rue du Haut-Bord Quebec City, G1N 4N7 Canada

February 22, 2018

#### Re: K171576

Trade/Device Name: The Panthera Anti-Snoring X3 Device Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: January 26, 2018 Received: January 29, 2018

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K171576

Device Name The Panthera Anti-Snoring X3 Device

Indications for Use (Describe)

The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching position, ready to pounce. Below the panther, the word "PANTHERA" is written in a stylized, sans-serif font, with the word "DENTAL" underneath in a smaller font. The text is in a purple color.

## 5. 510 (k) Summary

[As required by 21 CFR 807.92]

| Date Prepared: | February 21, 2018 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Panthera Dental Inc.<br>2035 rue du Haut-Bord<br>Québec (QC) G1N 4R7<br>Canada<br>Tel: [phone]<br>Fax: [phone] |
| Official Contact: | Martine Fortin<br>Quality Assurance and Regulatory Affairs Director<br>[e-mail]<br>Tel: [phone] |
| Device Trade Name: | Panthera Anti-Snoring X3 Device |
| Device Common Name: | Mandibular repositioning device |
| Classification: | 21 CFR 872.5570 (Class II) |
| Classification Name: | Intraoral devices for snoring and intraoral devices for<br>snoring and obstructive sleep apnea |
| Product code: | LRK |
| Primary Predicate: | The Panthera Anti-Snoring Device (K143244) |

SomnoDent Flex™ (K073004) Reference Devices: DynaFlex Anti-Snoring & Sleep Apnea Devices (K103076) MicrO2 Obstructive Sleep Apnea Device (K133683)

Description: The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two customized splints that fit separately over the upper and lower teeth.

The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharvngeal space, improving their ability to exchange air during sleep.

K171576

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Image /page/4/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching position, with its tail curled upwards. Below the panther, the word "PANTHERA" is written in a bold, sans-serif font, with a purple line underneath it. Below "PANTHERA", the word "DENTAL" is written in a smaller, sans-serif font.

The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The maximum protrusion of the device is 5 mm in 1 mm increments.

Indications for Use: The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Technological: The following table displays the differences and similarities between the Panthera Anti-Snoring X3 Device and four (4) other previously marketed devices. Equivalence is based on similarities in indications for use, materials of construction, design, operating principles, etc.

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Image /page/5/Picture/0 description: The image shows a black panther above the words "PANTHERA DENTAL" in purple. The panther is in a crouching position, with its tail curled up. The word "PANTHERA" is in a larger font than the word "DENTAL", and there is a horizontal line above the word "DENTAL".

Table 5.1: Comparison chart between the submitted device and the predicates.

| | The Panthera Anti-<br>Snoring X3 Device | Primary Predicate<br>The Panthera Anti-<br>Snoring Device<br>(K143244) | SomnoDent Flex™<br>(K073004) | Reference Devices | | | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|
| Feature | | | | DynaFlex Anti-<br>Snoring & Sleep<br>Apnea Devices<br>(K103076) | MicrO2 Obstructive<br>Sleep Apnea Device<br>(K133683) | | |
| Picture of the<br>device | Image: The Panthera Anti-Snoring X3 Device | Image: The Panthera Anti-Snoring Device | Image: SomnoDent Flex | Image: DynaFlex Anti-Snoring & Sleep Apnea Devices | Image: MicrO2 Obstructive Sleep Apnea Device | N/A | |
| Regulation<br>description | Intraoral device for<br>snoring and<br>obstructive sleep<br>apnea | Intraoral device for<br>snoring and<br>obstructive sleep<br>apnea | Intraoral device for<br>snoring and<br>obstructive sleep<br>apnea | Intraoral devices for<br>snoring and<br>obstructive sleep<br>apnea | Intraoral device for<br>snoring and<br>obstructive sleep<br>apnea | Same for all | |
| Class | Class II | Class II | Class II | Class II | Class II | Same for all | |
| Indications<br>for Use | To reduce or alleviate<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) in<br>adults | To reduce or alleviate<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) in<br>adults | To reduce or alleviate<br>night time snoring and<br>mild to moderate<br>obstructive sleep<br>apnea | To reduce night time<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) in<br>adults.<br>The devices are worn<br>while sleeping to<br>support the lower jaw | To reduce night time<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) in<br>adults. | Same as<br>primary<br>predicate and<br>similar to the<br>reference<br>predicates | |
| | | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-<br>Snoring X3 Device | The Panthera Anti-<br>Snoring Device<br>(K143244) | SomnoDent Flex™<br>(K073004) | DynaFlex Anti-<br>Snoring & Sleep<br>Apnea Devices<br>(K103076) | MicrO2 Obstructive<br>Sleep Apnea Device<br>(K133683) | | |
| | | | | in a forward position<br>prescribed by the<br>dentist, and is<br>removable by the<br>patient | | | |
| Materials of<br>construction | Made from polymers<br>(polyamide type 12),<br>supplied by EOS.<br>The device is metal-<br>free.<br>Highly resilient and<br>durable biocompatible<br>polymer material | Made from polymers<br>(polyamide type 12),<br>supplied by EOS.<br>The device is metal-<br>free.<br>Highly resilient and<br>durable biocompatible<br>polymer material | Made from SMH<br>BFlex which is a<br>proprietary soft<br>polymer that is<br>molecularly bonded to<br>the device's hard<br>surface acrylic.<br>Includes two metal<br>screws in the<br>maxillary appliance | Made from hard<br>acrylic outer shell and<br>soft vinyl liner inside.<br>Includes two metal<br>screws in the<br>maxillary appliance | Hard PMMA material | Same as<br>primary<br>predicate | |
| Design | Uses computer-aided<br>design (CAD) and<br>computer-aided<br>manufacturing<br>(CAM).<br>Uses CAD that<br>enables a high degree<br>of customization<br>according to the | Uses computer-aided<br>design (CAD) and<br>computer-aided<br>manufacturing<br>(CAM).<br>Uses CAD that<br>enables a high degree<br>of customization<br>according to the | Information not found | Information not found | Uses computer-aided<br>design (CAD) and<br>computer-aided<br>manufacturing<br>(CAM). | CAD/CAM<br>same as<br>primary<br>predicate and<br>Micro2 | |
| | | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-<br>Snoring X3 Device | The Panthera Anti-<br>Snoring Device<br>(K143244) | SomnoDent Flex™<br>(K073004) | DynaFlex Anti-<br>Snoring & Sleep<br>Apnea Devices<br>(K103076) | MicrO2 Obstructive<br>Sleep Apnea Device<br>(K133683) | | |
| | physician or dentist<br>prescription.<br>The CAM and<br>selective laser<br>sintering guarantee<br>precision, accuracy<br>and consistency for<br>each patient. | physician or dentist<br>prescription.<br>The CAM and<br>selective laser<br>sintering guarantee<br>precision, accuracy<br>and consistency for<br>each patient. | | | | | |
| | Two customized<br>splints that fit<br>separately over the<br>upper and lower teeth<br>inside the mouth. | Two customized<br>splints that fit<br>separately over the<br>upper and lower teeth<br>inside the mouth. | Two customized<br>splints that fit<br>separately over the<br>upper and lower teeth<br>inside the mouth. | Two customized<br>splints that fit<br>separately over the<br>upper and lower teeth<br>inside the mouth. | Two customized<br>splints that fit<br>separately over the<br>upper and lower teeth<br>inside the mouth. | Same for all<br>(customized<br>splints) | |
| | The mandible splint<br>contains wing<br>protrusions that<br>interface with the<br>incline blocks built<br>into the buccal of the<br>maxillary splint | The mandible splint<br>contains triangular<br>protrusions allowing<br>the splints to engage<br>by means of<br>interlocking rods on<br>the side. | The mandible splint<br>contains triangular<br>protrusions that<br>interface with the<br>incline blocks built<br>into the buccal of the<br>maxillary splint | The mandible splint<br>contains triangular<br>protrusions that<br>interface with the<br>incline blocks built<br>into the buccal of the<br>maxillary splint | The mandible splint<br>contains protrusions<br>that interface with the<br>block built into the<br>buccal of the<br>maxillary splint | Similar to<br>SomnoDent<br>and DynaFlex<br>which use<br>screw instead<br>of clip;<br>Similar to<br>primary<br>predicate<br>which uses | |
| | | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-<br>Snoring X3 Device | The Panthera Anti-<br>Snoring Device<br>(K143244) | SomnoDent Flex™<br>(K073004) | DynaFlex Anti-<br>Snoring & Sleep<br>Apnea Devices<br>(K103076) | MicrO2 Obstructive<br>Sleep Apnea Device<br>(K133683) | | |
| • Upper<br>splint | Bears on the posterior<br>teeth | Bears on the posterior<br>teeth | Stops after the first<br>molar, sometimes<br>after the second<br>premolar | Information not found | Information not found | rods instead of<br>clip<br>Same as<br>primarv<br>predicate | |
| • The<br>orientation of<br>the wings on<br>the lower<br>splint | Two wings at either<br>70°, 90° or 110°<br>(depending on the<br>model device chosen) | Two wings at 110° | Two wings at 70° | Two wings at 70° for<br>the Dorsal and 110°<br>for the Dorsal AirPlus | Two wings at 90° | Same as<br>predicates | |
| • Occlusion<br>trays | It stops after premolar<br>teeth | It stops after premolar<br>teeth | It covers the entire<br>occlusal surface of<br>upper and lower<br>retainers | It covers the entire<br>occlusal surface of<br>upper and lower<br>retainers | Information not found | Same as<br>primarv<br>predicate | |
| Principle of<br>operation/<br>means of<br>mandibular<br>advancement | Adjustment of the<br>relative position of the<br>splints guides the<br>mandible forward and<br>maintains<br>advancement thus<br>enlarging the airway. | Adjustment of the<br>relative position of the<br>splints guides the<br>mandible forward and<br>maintains<br>advancement thus<br>enlarging the airway. | Adjustment of the<br>relative position of the<br>splints guides the<br>mandible forward and<br>maintains<br>advancement thus<br>enlarging the airway. | Adjustment of the<br>relative position of the<br>splints guides the<br>mandible forward and<br>maintains<br>advancement thus<br>enlarging the airway. | Adjustment of the<br>relative position of the<br>splints guides the<br>mandible forward and<br>maintains<br>advancement thus<br>enlarging the airway. | Same for all | |
| | | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-<br>Snoring X3 Device | The Panthera Anti-<br>Snoring Device<br>(K143244) | SomnoDent Flex™<br>(K073004) | DynaFlex Anti-<br>Snoring & Sleep<br>Apnea Devices<br>(K103076) | MicrO2 Obstructive<br>Sleep Apnea Device<br>(K133683) | | |
| | The vertical opening<br>of the jaw is not fixed<br>in a single position | The vertical opening<br>of the jaw is not fixed<br>in a single position. | The vertical opening<br>of the jaw is not fixed<br>in a single position | The vertical opening<br>of the jaw is not fixed<br>in a single position | The vertical opening<br>of the jaw is not fixed<br>in a single position | | |
| | Push-based<br>mandibular<br>repositioning device,<br>allows for nasal and/or<br>oral breathing | Traction-based<br>mandibular<br>repositioning device,<br>allows for nasal and/or<br>oral breathing | Push-based<br>mandibular<br>repositioning device,<br>allows for nasal and/or<br>oral breathing | Push-based<br>mandibular<br>repositioning device,<br>allows for nasal and/or<br>oral breathing | Push-based<br>mandibular<br>repositioning device,<br>allows for nasal and/or<br>oral breathing | Same as<br>reference<br>predicates | |
| Fixed/<br>removable | Removable | Removable | Removable | Removable | Removable | Same for all | |
| Adjustment | Adjusted via the<br>adjustable clip<br>assembly placed on<br>each side of the<br>maxillary splint. The<br>longer the stop-clip is,<br>the further the<br>mandible is advanced.<br>The dentist can select<br>a longer stop-clip until<br>optimal advancement<br>is achieved. | Adjusted via the use<br>of interlocking rods<br>placed on each side of<br>the mandible splint.<br>The shorter the rod,<br>the further the<br>mandible is advanced.<br>The dentist can select<br>a shorter connecting<br>rod until optimal<br>advancement is<br>achieved. | Adjusted via the use<br>of the supplied<br>adjustment key when<br>inserting it in the<br>adjustable screw. The<br>adjustable screws are<br>placed on each side of<br>the maxillary splint.<br>The more it is<br>unscrewed, the further<br>the mandible is<br>advanced. The dentist<br>can select the proper | Adjusted via the use<br>of the supplied<br>adjustment key when<br>inserting it in the<br>adjustable screw. The<br>adjustable screws are<br>placed on each side of<br>the maxillary splint.<br>The more it is<br>unscrewed, the further<br>the mandible is<br>advanced. The dentist<br>can select the proper | Advancements can be<br>achieved by simply<br>removing the current<br>upper or lower device<br>and inserting the next<br>upper or lower device<br>in the mandibular<br>advancing series. | Similar to<br>SomnoDent<br>and DynaFlex<br>predicates | |
| | The Panthera Anti-<br>Snoring X3 Device | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-<br>Snoring Device<br>(K143244) | SomnoDent Flex™<br>(K073004) | DynaFlex Anti-<br>Snoring & Sleep<br>Apnea Devices<br>(K103076) | MicrO2 Obstructive<br>Sleep Apnea Device<br>(K133683) | | | |
| | Image: The Panthera Anti-Snoring X3 Device | | until optimal<br>advancement is<br>achieved.<br>Image: SomnoDent Flex | until optimal<br>advancement is<br>achieved.<br>Image: DynaFlex Anti-Snoring & Sleep Apnea Devices | Image: MicrO2 Obstructive Sleep Apnea Device | | |
| Mandibular<br>adjustment | Performed by dentist<br>or physician | Performed by dentist<br>or physician | Performed by dentist<br>or physician | Performed by dentist<br>or physician | Information not found | Same for all | |
| Mandibular<br>advancement<br>range | Up to 5 mm at 1 mm<br>increments | Up to 15 mm at 1 mm<br>increments | Up to 6.0 mm at 0.1<br>mm increments | Information not found | Up to 6.0 mm | Similar to<br>predicates<br>except<br>DynaFlex | |
| Supplied<br>sterile/non<br>sterile | Non sterile | Non sterile | Non sterile | Non sterile | Non sterile | Same for all | |
| Target<br>population | Adult patients | Adult patients | Adult patients | Adult patients | Adult patients | Same for all | |
| Single Use/<br>reusable | Reusable | Reusable | Reusable | Reusable | Reusable | Same for all | |
| Vertical<br>opening | Up to 6 mm | Up to 4 mm | Up to 4 mm | Information not found | Information not found | Similar to the<br>primary | |
| Feature | The Panthera Anti-<br>Snoring X3 Device | Primary Predicate | The Panthera Anti-<br>Snoring Device<br>(K143244) | SomnoDent Flex™<br>(K073004) | DynaFlex Anti-<br>Snoring & Sleep<br>Apnea Devices<br>(K103076) | MicrO2 Obstructive<br>Sleep Apnea Device<br>(K133683) | |
| Prescription/<br>OTC | Prescription only | Prescription only | Prescription only | Prescription only | Prescription only | Same for all | |
| Cleaning and<br>Maintenance | Clean daily in<br>lukewarm water with<br>a soft toothbrush.<br>Rinse, dry and store in<br>case provided. Twice<br>a week use<br>antibacterial<br>orthodontic cleansing<br>solution that are<br>chlorine-free | Clean daily in<br>lukewarm water with<br>a soft toothbrush.<br>Rinse, dry and store in<br>case provided. Twice<br>a week use<br>antibacterial<br>orthodontic cleansing<br>solution that are<br>chlorine-free | Clean daily in cold or<br>lukewarm water with<br>the brush provided or<br>a soft toothbrush and<br>mild detergent. Rinse,<br>dry, and store in case<br>provided. | Information not found | Clean daily | Same as<br>primary<br>predicate | |

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Image /page/6/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching position, with its tail curled upwards. Below the panther is the word "PANTHERA" in a bold, sans-serif font, with the word "DENTAL" underneath in a smaller font.

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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" in purple. The word "PANTHERA" is in a larger font than the word "DENTAL", and the two words are stacked on top of each other.

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Image /page/9/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black silhouette of a panther in a stalking pose, with its tail curled upwards. Below the panther is the text "PANTHERA" in a bold, sans-serif font, with the word "DENTAL" underneath in a smaller font.

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Image /page/10/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curved upwards. Below the panther, the word "PANTHERA" is written in a purple, sans-serif font, with the word "DENTAL" written in a smaller font size below it.

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Image /page/11/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 font and a purple color, while "DENTAL" is in a smaller font and a darker color.

Confidential

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Image /page/12/Picture/0 description: The image shows a logo for a dental company called Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther is the word "PANTHERA" in a stylized purple font, with the word "DENTAL" in a smaller font underneath.

Non-Clinical Testing: The non-clinical testing includes assessment of the physical properties of the Panthera Anti-Snoring X3 Device and its ability to achieve its intended use. The Panthera Anti-Snoring X3 Device meets criteria to support substantial equivalence to the primary and reference predicate devices. The Panthera Anti-Snoring X3 Device and the Panthera Anti-Snoring Device are substantially equivalent based on the fact that both devices use the same raw material, have the same indications for use, type and duration of patient contact as well as the same Selective Laser Sintering fabrication process including the proprietary manufacturing. Therefore, the performance testing provided in the primary predicate submission K143244 (Panthera Anti-Snoring Device) serves in lieu of performing the two (2) performance tests for the proposed device: orthosis polishing and static and dynamic compression resistance. A test was conducted to determine the build locations for 3-D printing in accordance with the FDA Guidance Document, Technical Considerations for Additive Manufactured Medical Devices and following the standards ASTM D638 and NISTIR 8059.

Biocompatibility: A biocompatibility assessment of the device was performed. The purpose of this assessment was to ensure that biocompatibility had been established for the proposed device following the standards of ISO 14971, ISO 10993-1, ISO 10993-5 and ISO 10993-10. The Panthera Anti-Snoring X3 Device is biocompatible, based on the use of the same materials of construction, the same supplier and the same proprietary manufacturing process as the primary predicate device, the Panthera Anti-Snoring Device, marketed by Panthera Dental Inc.

Fatigue Testing: Considering that the mechanism of action for the protrusion of the lower iaw is different between the Panthera AS X3 and the mechanism of the Panthera AS, performance testing were conducted on the stop-clip system assembly. The results have demonstrated that the Panthera AS X3 has sufficient mechanical strength for its intended clinical application.

Clinical Testing: Human clinical study was not deemed necessary to support substantial equivalence. The Panthera AS X3 does not use design dissimilar from the reference predicate devices, does not use new technologies different from the primary and reference predicate devices, and does not deviate from the indications for use identified in the primary and reference predicate devices.

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Image /page/13/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" in purple. The word "PANTHERA" is in a larger font than the word "DENTAL". The panther is facing left and has a long, curved tail.

Substantial Equivalence Conclusion: The Panthera Anti-Snoring X3 Device is considered to be substantially equivalent to the primary predicate and any differences have been identified in other previously cleared reference devices and do not impact safety and effectiveness.