| Device Type ID | 1200 |
| Device Name | Syringe, Cartridge |
| Regulation Description | Cartridge Syringe. |
| 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 | 872.6770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EJI |
| 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 | 1200 |
| Device | Syringe, Cartridge |
| Product Code | EJI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cartridge Syringe. |
| CFR Regulation Number | 872.6770 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED TECHNOLOGY AND CAPITAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Connection Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Break | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Milestone Scientific, Inc. | III | Jul-01-2015 |