IPS E.MAX CAD/IPS E.MAX ZIRCAD
FDA 510(k) clearance K051705 · decided 2005-10-14
Clearance details
- K-number
- K051705
- Device name
- IPS E.MAX CAD/IPS E.MAX ZIRCAD
- Applicant
- Ivoclar Vivadent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-24
- Decision date
- 2005-10-14
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- EIH
- Device class
- 2
- Regulation number
- 872.6660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Amherst, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of f recall (Z-1703-2024) | IVOCLAR VIVADENT AG | 2024-04-30 |
| IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of f recall (Z-1704-2024) | IVOCLAR VIVADENT AG | 2024-04-30 |
| IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fi recall (Z-1705-2024) | IVOCLAR VIVADENT AG | 2024-04-30 |
| IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fi recall (Z-1706-2024) | IVOCLAR VIVADENT AG | 2024-04-30 |
| IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fi recall (Z-1707-2024) | IVOCLAR VIVADENT AG | 2024-04-30 |
| IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fi recall (Z-1708-2024) | IVOCLAR VIVADENT AG | 2024-04-30 |