The following data is part of a premarket notification filed by Handae Chemical Co., Ltd. with the FDA for Correct Dental Impression Material.
| Device ID | K042860 |
| 510k Number | K042860 |
| Device Name: | CORRECT DENTAL IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | HANDAE CHEMICAL CO., LTD. 560-24, SONGDU-RI, JINCHEON-UP Jincheon-gun,chungcheongbuk-do, KR 365-802 |
| Contact | Jae Ho Yu |
| Correspondent | Jae Ho Yu HANDAE CHEMICAL CO., LTD. 560-24, SONGDU-RI, JINCHEON-UP Jincheon-gun,chungcheongbuk-do, KR 365-802 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-15 |
| Decision Date | 2004-12-03 |