The following data is part of a premarket notification filed by Gebdi Dental-products Gmbh with the FDA for Gebdi Tribos 501.
| Device ID | K092231 |
| 510k Number | K092231 |
| Device Name: | GEBDI TRIBOS 501 |
| Classification | Denture, Plastic, Teeth |
| Applicant | GEBDI DENTAL-PRODUCTS GMBH INDUSTRIESTR 3A Engen Bawu, DE 78234 |
| Contact | Thomas Biskupski |
| Correspondent | Thomas Biskupski GEBDI DENTAL-PRODUCTS GMBH INDUSTRIESTR 3A Engen Bawu, DE 78234 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-23 |
| Decision Date | 2009-11-24 |
| Summary: | summary |