The following data is part of a premarket notification filed by Swissmeda Ag with the FDA for Swissmeda Dental Planning System.
| Device ID | K112251 |
| 510k Number | K112251 |
| Device Name: | SWISSMEDA DENTAL PLANNING SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | SWISSMEDA AG TECHNOPARKSTRASSE 1 Zurich, CH 8005 |
| Contact | Jorg Danzberg |
| Correspondent | Jorg Danzberg SWISSMEDA AG TECHNOPARKSTRASSE 1 Zurich, CH 8005 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-05 |
| Decision Date | 2012-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07629999057654 | K112251 | 000 |
| 07649997938014 | K112251 | 000 |
| 60192155944543 | K112251 | 000 |
| 07629999062177 | K112251 | 000 |
| 07629999628410 | K112251 | 000 |
| 07629999614178 | K112251 | 000 |
| 07629999685093 | K112251 | 000 |
| 07629999061569 | K112251 | 000 |
| 07629999065512 | K112251 | 000 |
| 07629999054356 | K112251 | 000 |
| 07629999056220 | K112251 | 000 |
| 07629999056985 | K112251 | 000 |
| 07649997938021 | K112251 | 000 |