FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IPS InLine
DI: DIVO631849EN1
·
Model: 631849EN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IPS InLine
- Primary DI
- DIVO631849EN1
- Version / Model
- 631849EN
- Catalog Number
- 631849EN
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-27
- Public Version
- 3
- Public Version Date
- 2019-02-18
- Public Version Status
- Update
- Public Device Record Key
- e1a9c54c-2cf1-46d4-a540-2ccff1a6f1cc
- Distribution End Date
- 2019-02-10
Device Description
IPS InLine System Opaquer, IPS InLine System Shade, IPS InLine System Shade Incisal, IPS InLine System Stains, IPS InLine System Glaze Paste, IPS InLine One Dentcisal Powder, IPS InLine System Add-on (690°C), IPS Inline System Build-Up Liquid P/L, IPS InLine System Glaze and Stain Liquid, IPS InLine System Opaquer Liquid, IPS Model Sealer, IPS Ceramic Separating Liquid, var. accessories
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 | DIVO631849EN1 | HIBCC |