Definition: Intended To Provide A Soft Barrier Between Wired Mouth Hardware And Oral Mucosa.
Device Type ID | 1378 |
Device Name | Intraoral, Dental Foam Protector |
Physical State | Strip Of Polyethelene Foam |
Technical Method | Uses Non-latex Foam To Cover Wired Mouth Hardware. Foam Is Frictionally Retained By A Slit In Its Center. |
Target Area | Intraoral Between Metal Appliance On Teeth And Lip Or Cheek. |
Regulation Description | Intraoral Dental Wax. |
Regulation Medical Specialty | Dental |
Review Panel | Dental |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 872.6890 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | PFL |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1378 |
Device | Intraoral, Dental Foam Protector |
Product Code | PFL |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Intraoral Dental Wax. |
CFR Regulation Number | 872.6890 [🔎] |