The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Atlantis Crown Abutment, Atlantis Gemini +(tm) Abutment.
Device ID | K110356 |
510k Number | K110356 |
Device Name: | ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) 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 | 2011-02-07 |
Decision Date | 2011-06-10 |
Summary: | summary |