Panthera Occlusal Appliance - Single

GUDID 07540204000077

The Panthera Occlusal Appliance is indicated for protection of teeth and restorations from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.

Panthera Dentaire Inc

Removable dental occlusal splint, custom-made
Primary Device ID07540204000077
NIH Device Record Keyec081f92-1186-4a03-b7ac-381a92dffbea
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanthera Occlusal Appliance - Single
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
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
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
GS107540204000077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQCMouthguard, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-05
Device Publish Date2024-10-28

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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

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