The following data is part of a premarket notification filed by Astra Tech Inc. with the FDA for Atlantis Abutment For Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini + Abutment.
Device ID | K093483 |
510k Number | K093483 |
Device Name: | ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + 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 | 2009-11-09 |
Decision Date | 2009-12-22 |
Summary: | summary |