The following data is part of a premarket notification filed by Shandong Huge Dental Material Corporation with the FDA for Glass Ionomer Cement (luting).
| Device ID | K161851 |
| 510k Number | K161851 |
| Device Name: | Glass Ionomer Cement (Luting) |
| Classification | Cement, Dental |
| Applicant | SHANDONG HUGE DENTAL MATERIAL CORPORATION No. 68 Shanhai Road, Donggang District Rizhao City, CN 276800 |
| Contact | Steven Song |
| Correspondent | Steven Song SHANDONG HUGE DENTAL MATERIAL CORPORATION No. 68 Shanhai Road, Donggang District Rizhao City, CN 276800 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-06 |
| Decision Date | 2016-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970402670276 | K161851 | 000 |
| 06970402670252 | K161851 | 000 |