The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Flexitime Monophase Pro Scan.
| Device ID | K113574 |
| 510k Number | K113574 |
| Device Name: | FLEXITIME MONOPHASE PRO SCAN |
| Classification | Material, Impression |
| Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Contact | Chris Holden |
| Correspondent | Chris Holden HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-02 |
| Decision Date | 2012-07-13 |
| Summary: | summary |