The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Atlantis Abutment For Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment.
| Device ID | K101004 |
| 510k Number | K101004 |
| Device Name: | ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ASTRA TECH, INC. 8944 TAMAROA TERR. Skokie, IL 60076 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown ASTRA TECH, INC. 8944 TAMAROA TERR. 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 | 2010-04-12 |
| Decision Date | 2010-08-16 |
| Summary: | summary |