The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Estelite Sigma Quick.
| Device ID | K080940 |
| 510k Number | K080940 |
| Device Name: | ESTELITE SIGMA QUICK |
| Classification | Material, Tooth Shade, Resin |
| Applicant | TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith Barritt |
| Correspondent | Keith Barritt TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2008-06-19 |
| Summary: | summary |