The following data is part of a premarket notification filed by S-denti Co., Ltd. with the FDA for I-root.
| Device ID | K100450 |
| 510k Number | K100450 |
| Device Name: | I-ROOT |
| Classification | Locator, Root Apex |
| Applicant | S-DENTI CO., LTD. 505-14, GASAN-DONG GEUMCHEON-GU Seongnam-city, Seoul, KR 153-803 |
| Contact | Tae Kye Nam |
| Correspondent | Tae Kye Nam S-DENTI CO., LTD. 505-14, GASAN-DONG GEUMCHEON-GU Seongnam-city, Seoul, 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 | 2010-02-17 |
| Decision Date | 2010-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809455601105 | K100450 | 000 |
| 08809455601099 | K100450 | 000 |
| 08809455601082 | K100450 | 000 |
| 08809455601075 | K100450 | 000 |
| 08809455601051 | K100450 | 000 |