The following data is part of a premarket notification filed by Atlantis Components, Inc. with the FDA for Atlantis, Gemini And Gemini+ Abutments In Zirconia For Astra Implants.
| Device ID | K071946 |
| 510k Number | K071946 |
| Device Name: | ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS |
| 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 | 2007-07-13 |
| Decision Date | 2007-10-05 |
| Summary: | summary |