The following data is part of a premarket notification filed by Astra Tech Inc. with the FDA for Atlantis In Zirconia For Dentsply Ankylos Implant, Atlantis Later Abutment In Zirconia.
Device ID | K120338 |
510k Number | K120338 |
Device Name: | ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | ASTRA TECH INC. 8944 TAMAROA TERRACE Skokie, IL 60076 |
Contact | B A Brown |
Correspondent | B 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 | 2012-02-03 |
Decision Date | 2012-07-05 |
Summary: | summary |