The following data is part of a premarket notification filed by Universal Implant Systems, Inc. with the FDA for Octa-hex (tm) Implant Restoration Systems.
| Device ID | K905223 |
| 510k Number | K905223 |
| Device Name: | OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | UNIVERSAL IMPLANT SYSTEMS, INC. 4400 JENIFER STREET, N.W. SUITE 220 Washington, DC 20015 |
| Contact | Gerald Marlin |
| Correspondent | Gerald Marlin UNIVERSAL IMPLANT SYSTEMS, INC. 4400 JENIFER STREET, N.W. SUITE 220 Washington, DC 20015 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-08-16 |