Panthera Dental Inc

Address:9105 rue John-Simons,Quebec City,CA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Anti-Snoring (LRK) (2) Abutment, Implant, Dental, Endosseous (NHA) (1)

Premarket Exempt

Clear

The Panthera Anti-Snoring Device - 07540204000015 Catalog Number :

Device Description : The Panthera Anti-Snoring Device is a removable intraoral device used for treati The Panthera Anti-Snoring Device 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 and engage by means of adjustable rods. 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.

Device Class : 2

Duns Number: 203254607

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

The Panthera Anti-Snoring X3 Device - 07540204000022 Catalog Number :

Device Description : The Panthera Anti-Snoring X3 Device is a removable intraoral device used for tre 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 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.

Device Class : 2

Duns Number: 203254607

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Panthera Dental Milled Bar - 07540204000039 Catalog Number :

Device Description : The Panthera Dental Milled Bar is indicated for use as an accessory to an endoss The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

Device Class : 2

Duns Number: 203254607

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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