FDA UDI
In Commercial Distribution
🇺🇸 United States
IPS STYLE CERAM
DI: DIVO679925EN1
·
Model: 679925EN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IPS STYLE CERAM
- Primary DI
- DIVO679925EN1
- Version / Model
- 679925EN
- Catalog Number
- 679925
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-04
- Public Version
- 1
- Public Version Date
- 2019-03-07
- Public Version Status
- New
- Public Device Record Key
- 4dfd3e5e-0c1d-4e04-b15d-d1cf0a4a43c9
Device Description
IPS Style Ceram Pow. Opaquer 870 A1, A3, A3, A3.5, Deep Dentin A1, A2, A3, A3.5, Dentin A1, A2, A3, A3.5, Incisal I1, I2, I3, I4, 1x5g each Transpa neutral, Mamelon light, Occ. Dentin orange, Opal Effect 11, One 1, 2, 3, 4, IPS Ivocolor Shade Dentin SD1, SD2, Incisal SI1, IPS Ivocolor Essence EO1 white, EO4 sunset, E10 mahogany, E16 sapphire, IPS Ivocolor Glaze Pase, IPS Ivocolor Mixing Liquids (allround), IPS Pow. Opaquer Liquid, IPS Build-Up Liquid allround, Shade Guide IPS Style Ceram Impulse, Shade Guide IPS Style Ceram Incisal /Transpa
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
- Yes
- 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 | DIVO679925EN1 | HIBCC |