The following data is part of a premarket notification filed by S-denti Co., Ltd. with the FDA for Iroot 100 Mini.
| Device ID | K112153 |
| 510k Number | K112153 |
| Device Name: | IROOT 100 MINI |
| Classification | Locator, Root Apex |
| Applicant | S-DENTI CO., LTD. 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chung |
| Correspondent | Peter Chung S-DENTI CO., LTD. 300 ATWOOD Pittsburgh, PA 15213 |
| 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 | 2011-07-07 |
| Decision Date | 2012-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809455602126 | K112153 | 000 |
| 08809455602119 | K112153 | 000 |
| 08809455602102 | K112153 | 000 |
| 08809455602096 | K112153 | 000 |
| 08809455602089 | K112153 | 000 |
| 08809455602072 | K112153 | 000 |