The following data is part of a premarket notification filed by Neo Dental Chemical Products Co., Ltd. with the FDA for Vitapex Pre-loaded Dental Syringe.
| Device ID | K973667 |
| 510k Number | K973667 |
| Device Name: | VITAPEX PRE-LOADED DENTAL 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 | 1997-09-25 |
| Decision Date | 1997-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560128312554 | K973667 | 000 |
| 04560128312547 | K973667 | 000 |
| 04560128312530 | K973667 | 000 |