| 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 |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com | |
| Phone | 855-233-0388 |
| info@pantheradental.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07540204000022 [Previous] |
| GS1 | 07540204000060 [Primary] |
| LRK | Device, Anti-Snoring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-05 |
| Device Publish Date | 2024-10-28 |
| 07540204000046 - Panthera Dental Milled Bar | 2024-11-05 The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic devi |
| 07540204000053 - The Panthera Anti-Snoring Device | 2024-11-05 The Panthera D-SAD Classic is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apne |
| 07540204000060 - Panthera D-SAD X3 | 2024-11-05The 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. |
| 07540204000060 - Panthera D-SAD X3 | 2024-11-05 The Panthera D-SAD X3 is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It |
| 07540204000077 - Panthera Occlusal Appliance - Single | 2024-11-05 The Panthera Occlusal Appliance is indicated for protection of teeth and restorations from the forces and damage of parafunction |