The following data is part of a premarket notification filed by Dentalsafe Systems Pty., Ltd. with the FDA for Nil.
| Device ID | K935687 |
| 510k Number | K935687 |
| Device Name: | NIL |
| Classification | Mirror, Mouth |
| Applicant | DENTALSAFE SYSTEMS PTY., LTD. 2 GARDENERS ROAD KINGSFORD NSW 2032 Sydney, Australia, AU 2032 |
| Contact | Sydney Steen |
| Correspondent | Sydney Steen DENTALSAFE SYSTEMS PTY., LTD. 2 GARDENERS ROAD KINGSFORD NSW 2032 Sydney, Australia, AU 2032 |
| Product Code | EAX |
| Subsequent Product Code | ECP |
| Subsequent Product Code | EFL |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-29 |
| Decision Date | 1994-02-03 |