Friadent GmbH
Lake Forest, CA, US
Friadent GmbH appears in FDA device records in Lake Forest, CA. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Friadent GmbH between 1999 and 2004. The busiest year on record is 2003, with 6. The most recent is 2004, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 4 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 6 |
| 2004 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040170 | FRIADENT PLUS DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | |
| K041509 | ANKYLOS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K040946 | ANKYLOS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K032302 | XIVE TG ABUTMENTS | DZE | Substantially Equivalent | |
| K032284 | XIVE TG DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K032158 | XIVE DENTAL IMPLANT SYSTEM MULTIPLE | DZE | Substantially Equivalent | |
| K031674 | MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K024004 | XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K023799 | FRIOS ALGIPORE | LYC | Substantially Equivalent | |
| K021318 | XIVE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K013067 | FRIALOC DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K013867 | XIVE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K013438 | FRIALIT-2 ESTHETICBASE ABUTMENT | DZE | Substantially Equivalent | |
| K994174 | FRIALIT-2 MH-2 ABUTMENT | DZE | Substantially Equivalent | |
| K994376 | FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA | DZE | Substantially Equivalent | |
| K994298 | FRIOS MICROSAW | KMW | Substantially Equivalent | |
| K993560 | FRIALIT-2 BONE PROFILER | DZE | Substantially Equivalent | |
| K993095 | FRIALIT-2 SELECT COMPONENTS | DZE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain