FDA.reportPublic FDA data

Panthera Occlusal Appliance - Single

Primary DI
07540204000077
Brand
Panthera Occlusal Appliance - Single
Company
Panthera Dentaire Inc
Model
1
Device description
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.
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
MQCMouthguard, Prescription
OCOMouthguard, Migraine/Tension Headache

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU
OCOMouthguard, Migraine/Tension HeadacheUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203596000Panthera Occlusal AppliancePanthera Dental, Inc.2021-04-20MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540204000077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540204000077075402040000777540204000077

GMDN Terms#

Term, Definition table
TermDefinition
Removable dental occlusal splint, custom-madeA rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of synthetic polymer materials and manufactured to meet the needs of an individual patient. 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
07540204000053The Panthera Anti-Snoring Device12024-10-28
07540204000060Panthera D-SAD X312024-10-28
07540204000015The Panthera Anti-Snoring Device12016-09-23
07540204000039Panthera Dental Milled Bar12018-02-19

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