The following data is part of a premarket notification filed by Kmihh Ltd with the FDA for Le'pen.
| Device ID | K181597 |
| 510k Number | K181597 |
| Device Name: | Le'Pen |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | KMIHH Ltd 9 Hamovil Str., Kfar-saba, IL 4442411 |
| Contact | Or Ramot |
| Correspondent | Or Ramot KMIHH Ltd 9 Hamovil Str., Kfar-saba, IL 4442411 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-18 |
| Decision Date | 2019-04-01 |