The following data is part of a premarket notification filed by Ams with the FDA for Eclipse Kiss Zirconia.
| Device ID | K163238 |
| 510k Number | K163238 |
| Device Name: | Eclipse Kiss Zirconia |
| Classification | Powder, Porcelain |
| Applicant | AMS #530 NA-DONG MACHZONE, 117, HWANGGEUM-RO YANGCHON-EUP, GIMPO-SI Gyeonggi-do, KR 10048 |
| Contact | Hyuna Kim |
| Correspondent | Ho Dong Yang ONBIX CORPORATION #821 SAMIL. PLAZA, 837 -26 YEUKSAM-DONG GANGNAM-GU Seoul, KR 135768 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-18 |
| Decision Date | 2017-05-04 |