FDA UDI
In Commercial Distribution
🇺🇸 United States
IPS STYLE CERAM
DI: DIVO679923AN1
·
Model: 679923AN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IPS STYLE CERAM
- Primary DI
- DIVO679923AN1
- Version / Model
- 679923AN
- Catalog Number
- 679923AN
- 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
- 1282ebfb-d0df-409a-a321-524bd309b09b
Device Description
IPS Style Ceram Transpa neutral, blue, brown-grey, orange-grey, IPS Style light, yellow-orange, salmon, IPS Style Ceram Occ. Dentin orange, brown, IPS Style Ceram Incisal Edge, IPS Style Ceram Opal Effedct 1, 2, 3, 4, 5, violet, IPS Style Ceram Special Incisal yellow, grey, white-blue, IPS Style Ceram Int. Inc, IPS Style Ceram Cerv Transpa yellow, ora-pink, khaki, orange, Shade Guide IPS Ceram Impule, 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
- 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 | DIVO679923AN1 | HIBCC |