| Device Type ID | 1403 |
| Device Name | Locator, Root Apex |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LQY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1403 |
| Device | Locator, Root Apex |
| Product Code | LQY |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DENTSPLY INTERNATIONAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY TULSA DENTAL SPECIALTIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GOOD DOCTORS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Measurement | 263 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
Overheating Of Device | 2 |
Device Operates Differently Than Expected | 2 |
Measurement System Incompatibility | 1 |
False Reading From Device Non-Compliance | 1 |
Application Program Version Or Upgrade Problem | 1 |
Component Falling | 1 |
| Total Device Problems | 275 |