The following data is part of a premarket notification filed by Neo Dental Chemical Products Co., Ltd. with the FDA for Dentalis Kez Endodonitc Sealer.
| Device ID | K971642 |
| 510k Number | K971642 |
| Device Name: | DENTALIS KEZ ENDODONITC SEALER |
| Classification | Cement, Dental |
| Applicant | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 7613 CARTERET RD. Bethesda, MD 20817 |
| Contact | Kyle H Sibinovic |
| Correspondent | Kyle H Sibinovic NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 7613 CARTERET RD. Bethesda, MD 20817 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-02 |
| Decision Date | 1997-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560128312608 | K971642 | 000 |
| 04560128312592 | K971642 | 000 |
| 04560128312585 | K971642 | 000 |