The following data is part of a premarket notification filed by Innova Corp. with the FDA for Endopore Dental Implant Abutments.
| Device ID | K952434 |
| 510k Number | K952434 |
| Device Name: | ENDOPORE DENTAL IMPLANT ABUTMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INNOVA CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein INNOVA CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-24 |
| Decision Date | 1995-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307118541 | K952434 | 000 |
| 10841307117957 | K952434 | 000 |
| 10841307118022 | K952434 | 000 |
| 10841307118039 | K952434 | 000 |
| 10841307118046 | K952434 | 000 |
| 10841307118275 | K952434 | 000 |
| 10841307118282 | K952434 | 000 |
| 10841307118312 | K952434 | 000 |
| 10841307118329 | K952434 | 000 |
| 10841307118534 | K952434 | 000 |
| 10841307117933 | K952434 | 000 |