The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments For Astra Osseospeed 3.0 Implants.
Device ID | K081666 |
510k Number | K081666 |
Device Name: | ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS |
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 | 2008-06-13 |
Decision Date | 2008-10-07 |
Summary: | summary |