TD SLEEPZZ NIGHTGUARD 1CT PAD 12
The Doctor's - 1030450
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 IdentifiersDevice Id: 08711744032579
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 08711744032548
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Single
Device Id: 08711744032548
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