FDA UDI
In Commercial Distribution
🇺🇸 United States
IPS e.max CAD
DI: DIVO626375AL1
·
Model: 626375AL
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IPS e.max CAD
- Primary DI
- DIVO626375AL1
- Version / Model
- 626375AL
- Catalog Number
- 626375AL
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-27
- Public Version
- 2
- Public Version Date
- 2019-01-24
- Public Version Status
- Update
- Public Device Record Key
- 971e3c85-48fc-479f-b844-81b2d1c7cde2
Device Description
IPS e.max CAD for CEREC/inLab Blocks, IPS e.max CAD Crystall./Shades, IPS e.max CAD Crystall./Stains, IPS e.max CAD Crystall./Glaze Paste, IPS e.max CAD Crystall./Glaze Spray, IPS e.max CAD Crystall./Glaze Liquid, IPS e.max CAD Crystall./Add-On Liquid, IPS e.max CAD Crystall./Add-On, OptraGate, OptraDam, Virtual CADbite, IPS Neutralization Powder, IPS Ceramic Etching Gel, Multilink Primer A, Multilink Primer B, Multilink Automix, Monobond Plus, Proxyt, 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
- 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 | DIVO626375AL1 | HIBCC |