The following data is part of a premarket notification filed by Denx Advanced Dental Systems with the FDA for Igi-system.
| Device ID | K052840 |
| 510k Number | K052840 |
| Device Name: | IGI-SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | DENX ADVANCED DENTAL SYSTEMS MOSHAV ORA 106 Jerusalem, Al, IL 90880 |
| Contact | Rachel Weissbrod |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-07 |
| Decision Date | 2005-12-16 |
| Summary: | summary |