| Device Type ID | 1206 |
| Device Name | Agent, Polishing, Abrasive, Oral Cavity |
| Regulation Description | Oral Cavity Abrasive Polishing Agent. |
| 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 | 872.6030 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EJR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1206 |
| Device | Agent, Polishing, Abrasive, Oral Cavity |
| Product Code | EJR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Oral Cavity Abrasive Polishing Agent. |
| CFR Regulation Number | 872.6030 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WHIP-MIX CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 10 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Insufficient Information | 2 |
| Total Device Problems | 14 |