The following data is part of a premarket notification filed by Beijing C-root Dental Medical Devices Co., Ltd. with the FDA for Injectable Root Canal Bioceramic Sealer.
| Device ID | K212983 |
| 510k Number | K212983 |
| Device Name: | Injectable Root Canal Bioceramic Sealer |
| Classification | Resin, Root Canal Filling |
| Applicant | Beijing C-Root Dental Medical Devices Co., LTD. Room 301, Building 10, Yard 12, Middle Juyuan Road, Mapo Town,Shunyi District Beijing, CN 101300 |
| Contact | Bingmin Wu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801 ,No.161, East Lu Jiazui Rd., Pudong Shanghai, CN 200120 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-17 |
| Decision Date | 2021-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16972902583398 | K212983 | 000 |
| 16972902583282 | K212983 | 000 |
| 06972902581861 | K212983 | 000 |