The following data is part of a premarket notification filed by Shandong Huge Dental Material Corporation with the FDA for A-silicone For Bite Registration.
| Device ID | K201684 |
| 510k Number | K201684 |
| Device Name: | A-Silicone For Bite Registration |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2020-09-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970402675837 | K201684 | 000 |
| 00810132800597 | K201684 | 000 |
| 00810132800580 | K201684 | 000 |