The following data is part of a premarket notification filed by Dentkist, Inc with the FDA for Charmflex.
| Device ID | K152766 |
| 510k Number | K152766 |
| Device Name: | CharmFlex |
| Classification | Material, Impression |
| Applicant | DENTKIST, INC (DANGJEONG-DONG) 3, NONGSIM-RO Gunpo-si, KR 15842 |
| Contact | Shin Heang Lee |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-24 |
| Decision Date | 2016-03-08 |
| Summary: | summary |