The following data is part of a premarket notification filed by Shandong Huge Dental Material Corporation with the FDA for Orthodontic Appliance.
| Device ID | K181747 |
| 510k Number | K181747 |
| Device Name: | Orthodontic Appliance |
| Classification | Aligner, Sequential |
| Applicant | Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City, CN 276800 |
| Contact | Maggie Zheng |
| Correspondent | Maggie Zheng Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City, CN 276800 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2019-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970402670504 | K181747 | 000 |