The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Fiberfill Sgp.
| Device ID | K023819 |
| 510k Number | K023819 |
| Device Name: | FIBERFILL SGP |
| Classification | Gutta-percha |
| Applicant | PENTRON CLINICAL TECHNOLOGIES 53 NORTH PLAINS INDUSTRIAL RD. Wallingford, CT 06492 -0724 |
| Contact | Annmarie Tenero |
| Correspondent | Annmarie Tenero PENTRON CLINICAL TECHNOLOGIES 53 NORTH PLAINS INDUSTRIAL RD. Wallingford, CT 06492 -0724 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-15 |
| Decision Date | 2003-03-26 |