The following data is part of a premarket notification filed by Dio Corporation with the FDA for Dio Uf Hsa Internal Sub-merged Implant System.
Device ID | K122519 |
510k Number | K122519 |
Device Name: | DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | DIO CORPORATION 3540 WILSHIRE BLVD. SUITE 1104 Los Angeles, CA 90010 |
Contact | Timothy Lee |
Correspondent | Timothy Lee DIO CORPORATION 3540 WILSHIRE BLVD. SUITE 1104 Los Angeles, CA 90010 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-17 |
Decision Date | 2013-05-21 |
Summary: | summary |