The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium Flow.
| Device ID | K102770 |
| 510k Number | K102770 |
| Device Name: | FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-24 |
| Decision Date | 2010-12-21 |
| Summary: | summary |