FDA.reportPublic FDA data

The Panthera Anti-Snoring Device

Primary DI
07540204000053
Brand
The Panthera Anti-Snoring Device
Company
Panthera Dentaire Inc
Model
1
Device description
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.
Published
2024-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143244000The Panthera Anti-Snoring DevicePanthera Dental, Inc.2014-12-15LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540204000015PreviousGS10
07540204000053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540204000015075402040000157540204000015
07540204000053075402040000537540204000053

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep at room temperature
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-233-0388info@pantheradental.com

Regulatory Flags#

DUNS number
203254607
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540204000299Panthera D-Guide Single sided12026-04-06
07540204000305Panthera D-Guide Double sided12026-04-06
07540204000275Panthera D-SAD Classic Duo12025-11-28
07540204000282Panthera D-SAD X3 Duo12025-11-28
07540204000022The Panthera Anti-Snoring X3 Device12018-05-10
07540204000091Angulated Screwdriver Unigrip 30mm340142025-01-09
07540204000107Angulated Screwdriver 0.050 30mm340152025-01-09
07540204000114Angulated Screwdriver 0.048 30mm340162025-01-09
07540204000121Angulated Screwdriver KCS 30mm340172025-01-09
07540204000138Angulated Screwdriver Unigrip 20mm340182025-01-09
07540204000145Angulated Screwdriver 0.050 20mm340192025-01-09
07540204000152Angulated Screwdriver 0.048 20mm340202025-01-09
07540204000169Angulated Screwdriver KCS 20mm340212025-01-09
07540204000046Panthera Dental Milled Bar12024-10-28
07540204000060Panthera D-SAD X312024-10-28
07540204000077Panthera Occlusal Appliance - Single12024-10-28
07540204000015The Panthera Anti-Snoring Device12016-09-23
07540204000039Panthera Dental Milled Bar12018-02-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D775IBNR0Bonded Herbst-Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
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D775IBABN0Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
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