The following data is part of a premarket notification filed by "o" Co., Inc. with the FDA for Oco Dental Implant (5.0mm Diameter).
| Device ID | K023336 |
| 510k Number | K023336 |
| Device Name: | OCO DENTAL IMPLANT (5.0MM DIAMETER) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2002-10-09 |