Identity
- Trade Name
- IPS e.max ZirCAD FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- mat. for inlays, onlays, c&b FDA UDI
- Model / Reference
- 686804 FDA UDI
- Description
- mat. for inlays, onlays, c&b FDA UDI
Identifiers
- Catalog Number
- 686804 FDA UDI
- Primary DI / UDI-DI
- DIVO6868041 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, ceramic
The IPS e.max ZirCAD is a dental implant material designed for inlays, onlays, and crowns (C&B). This device is exempt from PM exemptions due to its ceramic composition, yet does not contain MRI safety information. It's primarily used in manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI 2fadb98d-ed18-4b67-aa0a-3f6a6e2abf7a 34 fields · synced Jul 17, 2026