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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660573420 | K091635 | 000 |
| J014660403550 | K091635 | 000 |
| J014660403570 | K091635 | 000 |
| J014660403580 | K091635 | 000 |
| J014660403590 | K091635 | 000 |
| J014660403600 | K091635 | 000 |
| J014660403610 | K091635 | 000 |
| J014660403620 | K091635 | 000 |
| J014660403630 | K091635 | 000 |
| J014660403540 | K091635 | 000 |
| J014660403530 | K091635 | 000 |
| J014661002690 | K091635 | 000 |
| J014661002700 | K091635 | 000 |
| J014661002710 | K091635 | 000 |
| J014661002720 | K091635 | 000 |
| J014661002730 | K091635 | 000 |
| J014661002740 | K091635 | 000 |
| J014661002750 | K091635 | 000 |
| J014661003060 | K091635 | 000 |
| J014660403640 | K091635 | 000 |
| J014660403650 | K091635 | 000 |
| J014660403770 | K091635 | 000 |
| J014660403780 | K091635 | 000 |
| J014660410510 | K091635 | 000 |
| J014660410520 | K091635 | 000 |
| J014660447430 | K091635 | 000 |
| J014660467930 | K091635 | 000 |
| J014660467940 | K091635 | 000 |
| J014660467950 | K091635 | 000 |
| J014660403760 | K091635 | 000 |
| J014660403750 | K091635 | 000 |
| J014660403670 | K091635 | 000 |
| J014660403680 | K091635 | 000 |
| J014660403690 | K091635 | 000 |
| J014660403700 | K091635 | 000 |
| J014660403710 | K091635 | 000 |
| J014660403720 | K091635 | 000 |
| J014660403730 | K091635 | 000 |
| J014660403740 | K091635 | 000 |
| J014661002680 | K091635 | 000 |