FDA UDI
In Commercial Distribution
🇺🇸 United States
IPS Style Ceram
DI: DIVO701899EN1
·
Model: 701899EN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
16
Basic Information
- Brand Name
- IPS Style Ceram
- Primary DI
- DIVO701899EN1
- Version / Model
- 701899EN
- Catalog Number
- 701899EN
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 16
- Record Status
- Published
- Publish Date
- 2019-11-12
- Public Version
- 1
- Public Version Date
- 2019-11-20
- Public Version Status
- New
- Public Device Record Key
- a3568de3-e3d7-41cf-8582-c786eafcb168
Device Description
"IPS Style Ceram Paste Opaq 5g A2, IPS Style Ceram Deep Dentin A2 5g, IPS Style Ceram Dentin A2 5g, IPS Style Ceram Incisal I2 5g, IPS Style Ceram Transpa neutral 5g, IPS Style Ceram Mamelon light 5g, IPS Style Ceram Occ. Dentin orange 5g, IPS Style Ceram Opal Effect 1 5g, IPS Style Ceram One 2 5g, Ivocolor Shade Dentin SD2 3g, IPS Ivocolor Essence 1.8g E01 white, IPS Ivocolor Essence 1.8g E04 sunset, IPS Ivocolor Glaze Paste 3g, Ivocolor Mixing Liquid allround 15ml, IPS Paste Opaq. Liquid 15ml, Build-Up Liquid 15ml 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 | DIVO701899EN1 | HIBCC | ||||
| Unit of Use | DIVO701899EN0 | HIBCC |