| Device Type ID | 1239 |
| Device Name | Scaler, Ultrasonic |
| Regulation Description | Ultrasonic Scaler. |
| 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) |
| CFR Regulation Number | 872.4850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ELC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1239 |
| Device | Scaler, Ultrasonic |
| Product Code | ELC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultrasonic Scaler. |
| CFR Regulation Number | 872.4850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DENTSPLY INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DMETEC CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ESSENTIAL DENTAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MECTRON SPA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANNING VV DENTAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SATELEC-ACTEON GROUP | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SONENDO, INC | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Overheating Of Device | 202 |
Break | 172 |
Restricted Flow Rate | 90 |
Tip | 54 |
Material Fragmentation | 12 |
Fracture | 8 |
Material Integrity Problem | 6 |
Volume Accuracy Problem | 6 |
Temperature Problem | 6 |
Device Operates Differently Than Expected | 4 |
Patient-Device Incompatibility | 2 |
Handpiece | 2 |
Inappropriate Shock | 2 |
Defective Component | 2 |
Melted | 2 |
Insufficient Information | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Switch, Push Button | 1 |
Scaler | 1 |
Hole In Material | 1 |
Material Separation | 1 |
Device Handling Problem | 1 |
Peeled / Delaminated | 1 |
No Flow | 1 |
Electrical /Electronic Property Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Cable | 1 |
| Total Device Problems | 584 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nakanishi Inc. | II | Aug-26-2016 |