The following data is part of a premarket notification filed by Aidi Biomedical Llc with the FDA for Aidi Dental Implant System.
Device ID | K123861 |
510k Number | K123861 |
Device Name: | AIDI DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | AIDI BIOMEDICAL LLC 34859 FREDERICK ST #105 Wildomar, CA 92595 |
Contact | Chen Tian |
Correspondent | Chen Tian AIDI BIOMEDICAL LLC 34859 FREDERICK ST #105 Wildomar, CA 92595 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-14 |
Decision Date | 2013-12-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D747IDI12371601 | K123861 | 000 |
D747IDI12371351 | K123861 | 000 |
D747IDI12371051 | K123861 | 000 |
D747IDI12370881 | K123861 | 000 |
D747IDI12331601 | K123861 | 000 |
D747IDI12331351 | K123861 | 000 |
D747IDI12331051 | K123861 | 000 |
D747IDI12330881 | K123861 | 000 |