The following data is part of a premarket notification filed by Atlantis Components, Inc. with the FDA for Atlantis Abutment And Atlantis Abutment Screw.
| Device ID | K981858 |
| 510k Number | K981858 |
| Device Name: | ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ATLANTIS COMPONENTS, INC. 270 THIRD ST. Cambridge, MA 02142 -1112 |
| Contact | Andrew Ziegler |
| Correspondent | Andrew Ziegler ATLANTIS COMPONENTS, INC. 270 THIRD ST. Cambridge, MA 02142 -1112 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-27 |
| Decision Date | 1999-03-22 |
| Summary: | summary |