DNTK CANKER RELIEF 6CT PATCH 24

DNTK CANKER RELIEF 6CT PATCH 24
Dentek - 00038904806A

A device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OLR

Device Name: Oral Wound Dressing

Device Class: U

Physical State: A viscous liquid or gel

Definition: Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Submission Type ID: 1

Review Panel: DE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Supplied as an oral rinse or as a gel, liquid or patch to be directly applied to an oral wound

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: Oral mucosal tissue

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 10047701001209

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00047701001202

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Single

Device Id: 00047701001202

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