The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Flexitime Fast & Scan Light Flow.
| Device ID | K120914 |
| 510k Number | K120914 |
| Device Name: | FLEXITIME FAST & SCAN LIGHT FLOW |
| Classification | Material, Impression |
| Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Contact | Jamie Mearna |
| Correspondent | Jamie Mearna HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-27 |
| Decision Date | 2012-07-25 |
| Summary: | summary |