The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Realseal Xt Sealer.
| Device ID | K102163 |
| 510k Number | K102163 |
| Device Name: | REALSEAL XT SEALER |
| Classification | Resin, Root Canal Filling |
| Applicant | KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garmen |
| Correspondent | Wendy Garmen KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2010-10-16 |
| Summary: | summary |