The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Tubli-seal, Tubli-seal Ewt,tubli-seal Xpress, Tubli-seal Ewt Xpress.
| Device ID | K153067 |
| 510k Number | K153067 |
| Device Name: | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress |
| Classification | Resin, Root Canal Filling |
| Applicant | SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
| Contact | Courtney Clark |
| Correspondent | Wendy Garman SYBRON DENTAL SPECIALTIES 1717 W. 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 | 2015-10-22 |
| Decision Date | 2016-07-27 |
| Summary: | summary |