The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Starflow Hv.
| Device ID | K020760 | 
| 510k Number | K020760 | 
| Device Name: | STARFLOW HV | 
| Classification | Material, Tooth Shade, Resin | 
| Applicant | DANVILLE MATERIALS, INC. 2021 OMEGA DR. San Ramon, CA 94583 | 
| Contact | Craig R Bruns | 
| Correspondent | Craig R Bruns DANVILLE MATERIALS, INC. 2021 OMEGA DR. San Ramon, CA 94583 | 
| Product Code | EBF | 
| CFR Regulation Number | 872.3690 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2002-03-07 | 
| Decision Date | 2002-05-03 | 
| Summary: | summary |