The following data is part of a premarket notification filed by Friadent Gmbh with the FDA for Frialit-2 Select Components.
| Device ID | K993095 |
| 510k Number | K993095 |
| Device Name: | FRIALIT-2 SELECT COMPONENTS |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 1999-12-09 |
| Summary: | summary |