The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Venus Diamond Flow.
| Device ID | K091635 |
| 510k Number | K091635 |
| Device Name: | VENUS DIAMOND FLOW |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Contact | Cheryl Zimmerman |
| Correspondent | Cheryl Zimmerman HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-04 |
| Decision Date | 2009-09-03 |
| Summary: | summary |