The following data is part of a premarket notification filed by Friadent Gmbh with the FDA for Modification To Frialit-2 Dental Implant System.
| Device ID | K031674 |
| 510k Number | K031674 |
| Device Name: | MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | FRIADENT GMBH 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson FRIADENT GMBH 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-30 |
| Decision Date | 2003-08-14 |
| Summary: | summary |