Panthera D-SAD X3

GUDID 07540204000060

The Panthera D-SAD X3 is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated 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 pharyngeal space, improving their ability to exchange air during sleep.

Panthera Dentaire Inc

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 07540204000060
• NIH Device Record Key: b19492fb-af1a-4f81-9aa1-5e4509c05397
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panthera D-SAD X3
• Version Model Number: 1
• Company DUNS: 203254607
• Company Name: Panthera Dentaire Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com
• Phone: 855-233-0388
• Email: info@pantheradental.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540204000022 [Previous]
GS1	07540204000060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143244

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-05
• Device Publish Date: 2024-10-28

Devices Manufactured by Panthera Dentaire Inc

• 07540204000091 - Angulated Screwdriver: 2025-01-17 Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous den
• 07540204000107 - Angulated Screwdriver: 2025-01-17 Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous den
• 07540204000114 - Angulated Screwdriver: 2025-01-17 Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous den
• 07540204000121 - Angulated Screwdriver: 2025-01-17 Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous den
• 07540204000138 - Angulated Screwdriver: 2025-01-17 Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous den
• 07540204000145 - Angulated Screwdriver: 2025-01-17 Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous den
• 07540204000152 - Angulated Screwdriver: 2025-01-17 Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous den
• 07540204000169 - Angulated Screwdriver: 2025-01-17 Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous den