The following data is part of a premarket notification filed by Osteo Implant Corp. with the FDA for Osteo Titanium Dental Implant.
| Device ID | K862854 |
| 510k Number | K862854 |
| Device Name: | OSTEO TITANIUM DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSTEO IMPLANT CORP. 2415 WILMINGTON RD. New Castle, PA 16105 |
| Contact | Steven B Lombardi |
| Correspondent | Steven B Lombardi OSTEO IMPLANT CORP. 2415 WILMINGTON RD. New Castle, PA 16105 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-29 |
| Decision Date | 1987-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D896325015SD0 | K862854 | 000 |
| D896325013SD0 | K862854 | 000 |
| D896325010SD0 | K862854 | 000 |
| D8963250115SD0 | K862854 | 000 |