The following data is part of a premarket notification filed by Spident Co., Ltd. with the FDA for Hexa-temp.
| Device ID | K214071 |
| 510k Number | K214071 |
| Device Name: | Hexa-Temp |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | SPIDENT CO., LTD. 203 & 312, Korea Industrial Complex, 722 Gojan-dong, Namdong-gu, KR 405-821 |
| Contact | J.m. Ahn |
| Correspondent | J.m. Ahn SPIDENT CO., LTD. 203 & 312, Korea Industrial Complex, 722 Gojan-dong, Namdong-gu, KR 405-821 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-03-10 |