The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Soluset Calcium Demineralizing Solution.
| Device ID | K864976 |
| 510k Number | K864976 |
| Device Name: | SOLUSET CALCIUM DEMINERALIZING SOLUTION |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | ENDO TECHNIC CORP. ONE APPLE HILL, STE 316 Natick, MA 01760 |
| Contact | Stewart Lustgarten |
| Correspondent | Stewart Lustgarten ENDO TECHNIC CORP. ONE APPLE HILL, STE 316 Natick, MA 01760 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-19 |
| Decision Date | 1987-02-27 |