The following data is part of a premarket notification filed by S-denti Co., Ltd. with the FDA for I-root 100.
| Device ID | K112508 |
| 510k Number | K112508 |
| Device Name: | I-ROOT 100 |
| Classification | Locator, Root Apex |
| Applicant | S-DENTI CO., LTD. VALLEY 6,481-4 GASAN-DONG GEUMCHEON-GU Tae Kye Nam, KR 153-803 |
| Contact | Tae K Nam |
| Correspondent | Tae K Nam S-DENTI CO., LTD. VALLEY 6,481-4 GASAN-DONG GEUMCHEON-GU Tae Kye Nam, KR 153-803 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-30 |
| Decision Date | 2012-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809455600672 | K112508 | 000 |
| 08809455600665 | K112508 | 000 |
| 08809455600658 | K112508 | 000 |
| 08809455600641 | K112508 | 000 |
| 08809455600634 | K112508 | 000 |