IPS e.max CAD
Basic Information
- Brand Name
- IPS e.max CAD
- Primary DI
- DIVO690813AL1
- Version / Model
- 690813AL
- Catalog Number
- 690813AL
- 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
- 2021-01-27
- Public Version Status
- Update
- Public Device Record Key
- 043100db-887c-4422-a3e8-d0141506c858
- Distribution End Date
- 2021-01-27
Device Description
IPS e.max CAD for CEREC/inLab A14 block, IPS e.max CAD for CEREC/inLab I12 block, IPS e.max CAD for CEREC/inLab C14 block, IPS e.max CAD for CEREC/inLab B32 block, IPS Empress CAD for CEREC/inLab I12 block, IPS Empress CAD for CEREC/inLab C14 blocks, IPS .max ZirCAD for CEREC/inLab C17 block, IPS e.max ZirCAD for CEREC/inLab B45 block, Telio CAD for CEREC/inLab B40L block, Telio CAD for CEREC/inLab A16 block, IPS Object Fix Putty, IPS e.max CAD Crystall./Glaze Liquid, IPS e.max CAD Crystall./Stains, IPS e.max CAD Crystall./Glaze Paste Fluo, IPS e.max CAD Crystall./Shade, IPS e.max CAD Crystallization Tray, Telio CS Desensitizer, SpeedCEM Plus, Adhese Universal, Variolink Esthetic DC, Monobond Etch & Prime, Ivoclean, SR Connect, Monobond Plus, Multilink Hybrid Abutment, 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 | DIVO690813AL1 | HIBCC |