The following data is part of a premarket notification filed by Osstem Germany Gmbh with the FDA for Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light.
| Device ID | K133527 |
| 510k Number | K133527 |
| Device Name: | SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT |
| Classification | Material, Impression |
| Applicant | OSSTEM GERMANY GMBH 85 BEN FAIRLESS DR Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim OSSTEM GERMANY GMBH 85 BEN FAIRLESS DR Fairless Hills, PA 19030 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-03-07 |
| Summary: | summary |