The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Atlantis Abutment In Zirconia For Astra Tech Osseospeed Plus Implant.
| Device ID | K112138 |
| 510k Number | K112138 |
| Device Name: | ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT |
| 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 | 2011-07-26 |
| Decision Date | 2011-12-01 |
| Summary: | summary |