The following data is part of a premarket notification filed by Tyds Biotech Incorporation with the FDA for Savdentm Mta Root Canal Filling Materials.
| Device ID | K162661 |
| 510k Number | K162661 |
| Device Name: | SavDenTM MTA Root Canal Filling Materials |
| Classification | Resin, Root Canal Filling |
| Applicant | tYDS Biotech Incorporation Rm. 7, 2F., No.229, Fuxing 2nd Rd Zhubei City, Hsinchu County, TW 302 |
| Contact | Liang-yu Chang |
| Correspondent | Liang-yu Chang tYDS Biotech Incorporation Rm. 7, 2F., No.229, Fuxing 2nd Rd Zhubei City, Hsinchu County, TW 302 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-04-25 |
| Summary: | summary |