The following data is part of a premarket notification filed by Neo Dental Chemical Products Co., Ltd. with the FDA for Neo Dental Endodontic Irrigation Syringe.
| Device ID | K955703 |
| 510k Number | K955703 |
| Device Name: | NEO DENTAL ENDODONTIC IRRIGATION SYRINGE |
| Classification | Resin, Root Canal Filling |
| 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 | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-14 |
| Decision Date | 1996-05-20 |