The following data is part of a premarket notification filed by Innova Life Sciences Corp. with the FDA for 5.0 X 5mm Endopore Endosseous Dental Implant System.
| Device ID | K032140 |
| 510k Number | K032140 |
| Device Name: | 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INNOVA LIFE SCIENCES CORP. 555 13TH ST. N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein INNOVA LIFE SCIENCES CORP. 555 13TH ST. N.W. Washington, DC 20004 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-11 |
| Decision Date | 2003-10-02 |
| Summary: | summary |