Definition: For Use On Dental Restorations, External To The Mouth, Prior To Insertion Into The Mouth.
| Device Type ID | 1384 |
| Device Name | External Cleaning Solution |
| Physical State | Solution Consists Of A Gel Or Liquid That Is Applied Directly To The Dental Restoration. |
| Technical Method | Applied Manually By Applicator To The Dental Restoration, Then Rinsed Thoroughly With Water And Air Dried Before Placement In The Mouth. |
| Target Area | The Target Area Of The Body Is A Tooth Which Will Have The Dental Restoration Applied To It. |
| Regulation Description | Cavity Varnish. |
| 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 | 872.3260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PME |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1384 |
| Device | External Cleaning Solution |
| Product Code | PME |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cavity Varnish. |
| CFR Regulation Number | 872.3260 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BISCO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENALI CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |