The following data is part of a premarket notification filed by Osteo Implant Corp. with the FDA for Bone Drill.
| Device ID | K945706 |
| 510k Number | K945706 |
| Device Name: | BONE DRILL |
| 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 | 1994-11-21 |
| Decision Date | 1995-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D896TD600 | K945706 | 000 |
| D896ADTD38S0 | K945706 | 000 |
| D896ADTD380 | K945706 | 000 |
| D896ADTD34S0 | K945706 | 000 |
| D896ADTD340 | K945706 | 000 |
| D896ADTD32T0 | K945706 | 000 |
| D896ADTD32S0 | K945706 | 000 |
| D896ADTD320 | K945706 | 000 |
| D896ADTD30S0 | K945706 | 000 |
| D896ADTD300 | K945706 | 000 |
| D896ADTD28S0 | K945706 | 000 |
| D896ADTD280 | K945706 | 000 |
| D896ADTD23S0 | K945706 | 000 |
| D896ADTD230 | K945706 | 000 |
| D896ADTD20S0 | K945706 | 000 |
| D896ADTD440 | K945706 | 000 |
| D896ADTD44S0 | K945706 | 000 |
| D896ADTD45T0 | K945706 | 000 |
| D896TD500 | K945706 | 000 |
| D896TD400 | K945706 | 000 |
| D896LD0 | K945706 | 000 |
| D896FSD24160 | K945706 | 000 |
| D896FSD24130 | K945706 | 000 |
| D896FSD241150 | K945706 | 000 |
| D896FSD24100 | K945706 | 000 |
| D896ADTD57T0 | K945706 | 000 |
| D896ADTD54S0 | K945706 | 000 |
| D896ADTD540 | K945706 | 000 |
| D896ADTD51S0 | K945706 | 000 |
| D896ADTD510 | K945706 | 000 |
| D896ADTD48S0 | K945706 | 000 |
| D896ADTD480 | K945706 | 000 |
| D896ADTD200 | K945706 | 000 |