The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment, Atlantis Gemini + Straumann Bone.
Device ID | K083871 |
510k Number | K083871 |
Device Name: | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE |
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 | 2008-12-29 |
Decision Date | 2009-04-15 |
Summary: | summary |