FDA UDI
In Commercial Distribution
🇺🇸 United States
IPS STYLE CERAM
DI: DIVO679924EN1
·
Model: 679924EN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IPS STYLE CERAM
- Primary DI
- DIVO679924EN1
- Version / Model
- 679924EN
- Catalog Number
- 679924
- 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
- d6029102-1da7-4899-8912-25b590e9d637
Device Description
IPS Style Ceram Pow. Opaquer 870 A2, Deep Dentin A2, Dentin A2, Incisal I2, Transpa neutral, Mamelon light, Occ. Dentin orange, Opal Effect, One 2, IPS Ivocolor Shade Dentin SD2, IPS Ivolor Essence EO1 white, EO4 sunset, IPS Ivocolor Glaze Paste, IPS Ivocolor Mixing Liquids (allround), Pow. Opaquer Liquid, Build-Up Liquid allround
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 | DIVO679924EN1 | HIBCC |