The following data is part of a premarket notification filed by Astra Tech Inc. with the FDA for Atlantis(tm) Abutment And Atlantis(tm) Crown Abutment For Keystone Genesis Implant, Atlantis Gemini(tm) Abutment....
| Device ID | K113003 |
| 510k Number | K113003 |
| Device Name: | ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ASTRA TECH INC. 8944 TAMAROA TERRACE Skokie, IL 60076 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown ASTRA TECH 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 | 2011-10-07 |
| Decision Date | 2012-03-01 |
| Summary: | summary |