The following data is part of a premarket notification filed by Boehringer/miter, Inc. with the FDA for Titanaloy Submersible Implant System.
| Device ID | K830414 |
| 510k Number | K830414 |
| Device Name: | TITANALOY SUBMERSIBLE IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BOEHRINGER/MITER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-08 |
| Decision Date | 1983-03-24 |