Panthera D-SAD Classic Duo

GUDID 07540204000275

The Panthera D-SAD Classic 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 ID07540204000275
NIH Device Record Keyafdefbcb-e008-4995-a858-2ff594ff1e2e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanthera D-SAD Classic Duo
Version Model Number1
Company DUNS203254607
Company NamePanthera Dentaire Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com
Phone855-233-0388
Emailinfo@pantheradental.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS107540204000275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-08
Device Publish Date2025-11-28

Devices Manufactured by Panthera Dentaire Inc

07540204000275 - Panthera D-SAD Classic Duo2025-12-08The Panthera D-SAD Classic 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.
07540204000275 - Panthera D-SAD Classic Duo2025-12-08 The Panthera D-SAD Classic is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apne
07540204000282 - Panthera D-SAD X3 Duo2025-12-08 The Panthera D-SAD X3 is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It
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
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