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 [🔎] |