The following data is part of a premarket notification filed by Materialise Dental Nv with the FDA for Simplant Immediate Smile Dental Care System.
| Device ID | K113739 |
| 510k Number | K113739 |
| Device Name: | SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | MATERIALISE DENTAL NV TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Geert Appeltans |
| Correspondent | Geert Appeltans MATERIALISE DENTAL NV TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Product Code | LLZ |
| Subsequent Product Code | DZE |
| Subsequent Product Code | EBG |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-20 |
| Decision Date | 2012-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07392532177286 | K113739 | 000 |
| 07392532177279 | K113739 | 000 |