||intraoral, dental foam protector|
||Intraoral dental wax.|
||Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
||Strip of polyethelene foam
||Uses non-latex foam to cover wired mouth hardware. Foam is frictionally retained by a slit in its center.
||intraoral between metal appliance on teeth and lip or cheek.
|Regulation Medical Specialty
Office of Device Evaluation
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
Dental Devices Branch (DEDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.|
|If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
|Third Party Review
||Not Third Party Eligible