The following data is part of a premarket notification filed by Enlighten Materials Co., Ltd with the FDA for Aa Temp Temporary Restoration 3d Printing Photoreactive Resin.
| Device ID | K191590 |
| 510k Number | K191590 |
| Device Name: | AA Temp Temporary Restoration 3D Printing Photoreactive Resin |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Enlighten Materials Co., Ltd 8F., NO.138, Sec.2, Jinshan S. Rd., Da-an Dist Taipei, TW 10642 |
| Contact | Jiun Ming Su |
| Correspondent | Chih-hao Kao Voler Biotech Consulting Co., Ltd. No. 3-1, Ln 58, Hejiang St., Zhongshan Dist., Taipei City, TW 10480 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2020-05-05 |