The following data is part of a premarket notification filed by Atlantis Components, Inc. with the FDA for Atlantis Abutment For 3i Certain Micro Mini; Gemini And Gemini+ Abutment.
| Device ID | K062197 |
| 510k Number | K062197 |
| Device Name: | ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ATLANTIS COMPONENTS, INC. 8944 TAMAROA TERRACE Skokie, IL 60076 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown ATLANTIS COMPONENTS, INC. 8944 TAMAROA TERRACE Skokie, IL 60076 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-01 |
| Decision Date | 2007-02-28 |
| Summary: | summary |