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 |