The following data is part of a premarket notification filed by Atlantis Components, Inc. with the FDA for Atlantis Abutment For Keystone Implant, Atlantis Gemini Abutment.
Device ID | K103020 |
510k Number | K103020 |
Device Name: | ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | ATLANTIS COMPONENTS, INC. 8944 TAMAROA TERRACE Skokie, IL 60076 |
Contact | Betsy Brown |
Correspondent | Betsy Brown ATLANTIS COMPONENTS, 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 | 2010-10-12 |
Decision Date | 2011-02-03 |
Summary: | summary |