IPS E.MAX CAD
Basic Information
- Brand Name
- IPS E.MAX CAD
- Primary DI
- DIVO703745AL1
- Version / Model
- 703745AL
- Catalog Number
- 703745
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-29
- Public Version
- 2
- Public Version Date
- 2022-02-07
- Public Version Status
- Update
- Public Device Record Key
- 36f1ff89-fe74-4427-a81d-b67510422fb3
- Distribution End Date
- 2022-02-04
Device Description
IPS e.max CAD CEREC inLab HT A2 I12 5, IPS e.max CAD CEREC inLab MT A2 C14 5, IPS e.max CAD CEREC inLab LT A2 B32 3, IPS Object Fix Putty 10 g, IPS e.max CAD Crystall Glaze Liquid 15ml, IPS e.max CAD Crystall Glaze Liquid 15ml, IPS e.max CAD Crystall. Shade 3g I1, IPS e.max CAD Cryst GlazePaste FLUO 3g, IPS e.max CAD Crystallization Tray, IPS Empress CAD CEREC inLab HT A2 I12 5, IPS Empress CAD CEREC inLab LT A2 C14 5, Empress CAD CEREC inLab Multi A2 C14 L 5, Tetric CAD CEREC inLab HT A2 I12 5, Tetric CAD CEREC inLab MT A2 C14 5, IPS e.max ZirCAD CER in.MT Mul. A2 C17 5, IPS e.max ZirCAD CER in.MT Mul. A2 B45 3, Telio CAD CEREC inLab LT A2 B40L 3, Telio CS desensitizer 5g (Bulk), SR Connect 5 ml ohne FS, FLA Monobond Plus 1g Bulk, Telio CAD CER inLab LT A2 A16 (L) 3, IPS e.max CAD CER inLab LT A2 A14 (L) 5, Multilink Abutment DS SPR HO0 2.5g, Variolink Esthetic DC 2.5ml SPR ntr 2.5g, AdheSE Universal 0.5ml VivaPen (BULK), SpeedCEM2014 DS SPR2.5ml transp 2.5g, OptraPol Test Pack, OptraFine Promo Pack
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 | DIVO703745AL1 | HIBCC |