Panthera Occlusal Appliance - Single

FDA UDI

Class U (US FDA UDI)

by Panthera Dentaire Inc

Identity

Trade Name: Panthera Occlusal Appliance - Single FDA UDI
Generic Name: Removable dental occlusal splint, custom-made FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 1 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 07540204000077 FDA UDI
510(k) Number: K203596 FDA UDI
FDA Product Code: MQC FDA UDI
OCO FDA UDI
GMDN Term: Removable dental occlusal splint, custom-made FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Removable dental occlusal splint, custom-made

Panthera Occlusal Appliance - Single by Panthera Dentaire Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Removable dental occlusal splint, custom-made.

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M-PM Crystal — Merz Dental GmbH · U
M-PM Crystal — Merz Dental GmbH · U

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Panthera Dentaire Inc

Sources (1)

FDA UDI ec081f92-1186-4a03-b7ac-381a92dffbea 36 fields · synced May 30, 2026