The following data is part of a premarket notification filed by Mem Dental Technology Co., Ltd with the FDA for Ceramic Bracket.
| Device ID | K180952 |
| 510k Number | K180952 |
| Device Name: | Ceramic Bracket |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | MEM Dental Technology Co., Ltd 2F., No.22, Ln.31, Sec.1, Huandong Rd., Xinshi Dist. Tainan City, TW 74146 |
| Contact | Anita Chen |
| Correspondent | Anita Chen MEM Dental Technology Co., Ltd 2F., No.22, Ln.31, Sec.1, Huandong Rd., Xinshi Dist. Tainan City, TW 74146 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-11 |
| Decision Date | 2019-06-07 |