Definition: To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation.
| Device Type ID | 1369 |
| Device Name | Handpiece, Air-powered, Root Canal Irrigation |
| Physical State | It Is Composed Or Aluminum, Stainless Steel And Plastic |
| Technical Method | It Is Attached To The Coupling For The Dental Handpiece And Is Used To Provide Irrigation Solution Into The Root Canal |
| Target Area | It Is Used To Treat A Tooth During A Root Canal Procedure |
| Regulation Description | Dental Handpiece And Accessories. |
| 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 | 872.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NYL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1369 |
| Device | Handpiece, Air-powered, Root Canal Irrigation |
| Product Code | NYL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Handpiece And Accessories. |
| CFR Regulation Number | 872.4200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KERR CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON DENTAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRONENDO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |