The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore Cylindrical Hex Hydroxyapatite Coated Implant, 3.3 Mm Diam..
| Device ID | K922872 |
| 510k Number | K922872 |
| Device Name: | INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Contact | William A Franklin |
| Correspondent | William A Franklin INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-15 |
| Decision Date | 1994-07-25 |