FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IPS InLine
DI: DIVO593003EN1
·
Model: 593003EN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IPS InLine
- Primary DI
- DIVO593003EN1
- Version / Model
- 593003EN
- Catalog Number
- 593003EN
- 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
- 246e1fc4-a4c0-4e80-b8d4-517abf59d4b5
- Distribution End Date
- 2019-02-10
Device Description
IPS InLine/IPS InLine PoM Opaque Paste, IPS InLine/IPS InLine PoM Glaze Paste, IPS InLine Dentin Powder, IPS InLine Incisal Powder, IPS InLine Transpa Powder, IPS InLine Add-On Powder, IPS InLine/IPS InLine PoM Build-Up Liquid, IPS InLine/IPS InLine PoM Opaquer Liquid, IPS InLine/IPS InLine PoM Glaze and Stains Liquid, IPS Model Sealer, IPS Ceramic Separating Liquid, Shade Guides, Chromascop Shade Guide
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 | DIVO593003EN1 | HIBCC |