- Physicians Office Resource

TD NIGHTGUARD ADVANCED CND 12
The Doctor's - 79932E

Device Description

A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OBR

Device Name: Mouthguard, Over-The-Counter

Device Class: U

Physical State: It is a material similar to a hard methylmethacrylate or a softer thermoplastic resin.

Definition: To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Submission Type ID: 1

Review Panel: DE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The dental mouthguard is a removable appliance that is fitted to the teeth by taking an immpression of the teeth or using a thermoplastic resin

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: Oral Cavity

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 10042037799325

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00042037799328

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Single

Device Id: 00042037799328

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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