The following data is part of a premarket notification filed by Dirotian Pty. Ltd. with the FDA for Dene Bridge.
| Device ID | K903672 |
| 510k Number | K903672 |
| Device Name: | DENE BRIDGE |
| Classification | Denture Preformed (partially Prefabricated Denture) |
| Applicant | DIROTIAN PTY. LTD. 6A ADDISON ROAD PENNINGTON 5013 South Australia, AU |
| Contact | Richard Burgess |
| Correspondent | Richard Burgess DIROTIAN PTY. LTD. 6A ADDISON ROAD PENNINGTON 5013 South Australia, AU |
| Product Code | EKO |
| CFR Regulation Number | 872.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-14 |
| Decision Date | 1990-12-05 |