FDA UDI
In Commercial Distribution
🇺🇸 United States
IPS e.max Ceram
DI: DIVO596835AN1
·
Model: 596835AN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IPS e.max Ceram
- Primary DI
- DIVO596835AN1
- Version / Model
- 596835AN
- Catalog Number
- 596835AN
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-27
- Public Version
- 3
- Public Version Date
- 2020-05-13
- Public Version Status
- Update
- Public Device Record Key
- c3ce9440-d678-4075-8261-ef25a133ae9e
Device Description
IPS e.max Ceram Occlusal Dentin orange, Occlusal Dentin brown, Mamelon light, Mamelon yellow-orange, Mamelon salmon, Opal Effect OE1, Opfal Effect OE2, Opal Effect OE4, Opal Effect OE5, Transpa blue, Transpa brown-grey, Transpa orange-grey, Incisal Edge, Special Incisal yellow, Special Incisal grey, Inter Incisal white-blue, Cervical Tranpa yellow, Cervical Transap ora-pink, Cervical Transpa khaki, Cervical Transpa orange, IPS e.max Ceram Impulse Shade Guide
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIH | POWDER, PORCELAIN | Dental | 872.6660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16187 | Dental appliance fabrication material, ceramic | A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | DIVO596835AN1 | HIBCC |