The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Sealapex Tubes, Sealapex Bulk Package, Sealapex Xpress Dual-barrel Syringes.
| Device ID | K152959 |
| 510k Number | K152959 |
| Device Name: | Sealapex Tubes, Sealapex Bulk Package, Sealapex Xpress Dual-barrel Syringes |
| Classification | Resin, Root Canal Filling |
| Applicant | Sybron Dental Specialties 1717 W. Collins Ave Orange, CA 92867 |
| Contact | Courtney Clark |
| Correspondent | Wendy Garman Sybron Dental Specialties 1717 W. Collins Ave Orange, CA 92867 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-07 |
| Decision Date | 2016-04-14 |
| Summary: | summary |