The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Set Canal Sealer Paste.
| Device ID | K862129 |
| 510k Number | K862129 |
| Device Name: | SET CANAL SEALER PASTE |
| Classification | Gutta-percha |
| 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 | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-07-22 |