The following data is part of a premarket notification filed by Psm Medical Solutions with the FDA for Psm Lomas / Benefit Screws.
| Device ID | K110392 |
| 510k Number | K110392 |
| Device Name: | PSM LOMAS / BENEFIT SCREWS |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | PSM MEDICAL SOLUTIONS SCHWARZWALDSTRASSE 5 Tuttlingen Bw, DE 78532 |
| Contact | Andrea Pecsi |
| Correspondent | Andrea Pecsi PSM MEDICAL SOLUTIONS SCHWARZWALDSTRASSE 5 Tuttlingen Bw, DE 78532 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-12-14 |
| Summary: | summary |