The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Herculite Ultra.
| Device ID | K082671 |
| 510k Number | K082671 |
| Device Name: | HERCULITE ULTRA |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SYBRON DENTAL SPECIALTIES 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman SYBRON DENTAL SPECIALTIES 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2008-12-11 |
| Summary: | summary |