Device Type ID | 1193 |
Device Name | Probe, Periodontic |
Regulation Description | Dental Hand Instrument. |
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 | 872.4565 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | EIX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 1193 |
Device | Probe, Periodontic |
Product Code | EIX |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Dental Hand Instrument. |
CFR Regulation Number | 872.4565 [🔎] |
Device Problems | |
---|---|
Naturally Worn | 1 |
Defective Component | 1 |
Bent | 1 |
Fracture | 1 |
Total Device Problems | 4 |