| Device Type ID | 1409 |
| Device Name | Cord, Retraction |
| 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 | MVL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1409 |
| Device | Cord, Retraction |
| Product Code | MVL |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KERR CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MICROCOPY, DIV. OF NEO-FLO INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PAC-DENT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON DENTAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ULTRADENT PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |