The following data is part of a premarket notification filed by "o" Co., Inc. with the FDA for Immediate Stabilizing Implant (isi).
| Device ID | K033392 |
| 510k Number | K033392 |
| Device Name: | IMMEDIATE STABILIZING IMPLANT (ISI) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | "O" CO., INC. 600 PAISANO, N.E., SUITE A Albuquerque, NM 87123 |
| Contact | David D Dalise |
| Correspondent | David D Dalise "O" CO., INC. 600 PAISANO, N.E., SUITE A Albuquerque, NM 87123 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-23 |
| Decision Date | 2003-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D785ISI5016OB0 | K033392 | 000 |
| D785ISI4010OB0 | K033392 | 000 |
| D785ISI4010CB0 | K033392 | 000 |
| D785ISI4008OB0 | K033392 | 000 |
| D785ISI4008CB0 | K033392 | 000 |
| D785ISI32516OB0 | K033392 | 000 |
| D785ISI32516CB0 | K033392 | 000 |
| D785ISI32514OB0 | K033392 | 000 |
| D785ISI32514CB0 | K033392 | 000 |
| D785ISI32512OB0 | K033392 | 000 |
| D785ISI32512CB0 | K033392 | 000 |
| D785ISI32510OB0 | K033392 | 000 |
| D785ISI32510CB0 | K033392 | 000 |
| D785ISI32508OB0 | K033392 | 000 |
| D785ISI4012CB0 | K033392 | 000 |
| D785ISI4012OB0 | K033392 | 000 |
| D785ISI5016CB0 | K033392 | 000 |
| D785ISI5014OB0 | K033392 | 000 |
| D785ISI5014CB0 | K033392 | 000 |
| D785ISI5012OB0 | K033392 | 000 |
| D785ISI5012CB0 | K033392 | 000 |
| D785ISI5010OB0 | K033392 | 000 |
| D785ISI5010CB0 | K033392 | 000 |
| D785ISI5008OB0 | K033392 | 000 |
| D785ISI5008CB0 | K033392 | 000 |
| D785ISI4016OB0 | K033392 | 000 |
| D785ISI4016CB0 | K033392 | 000 |
| D785ISI4014OB0 | K033392 | 000 |
| D785ISI4014CB0 | K033392 | 000 |
| D785ISI32508CB0 | K033392 | 000 |