FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IPS E.MAX CAD
DI: DIVO690811AL1
·
Model: 690811AL
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
19
Basic Information
- Brand Name
- IPS E.MAX CAD
- Primary DI
- DIVO690811AL1
- Version / Model
- 690811AL
- Catalog Number
- 690811
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 19
- Record Status
- Published
- Publish Date
- 2020-03-02
- Public Version
- 2
- Public Version Date
- 2022-04-21
- Public Version Status
- Update
- Public Device Record Key
- aa3d972c-e800-4234-a5f4-5623a4d9b5c0
- Distribution End Date
- 2022-04-20
Device Description
IPS e.max CAD for PrograMill I12 block, IPS e.max CAD for PrograMill C14 block, IPS e.max CAD for PrograMill B32 block, IPS Empress CAD for PrograMill I12 block, IPS Empress CAD for PrograMill C14 block, IPS Empress CAD for PrograMill C14 L block, IPS e.max ZirCAD for PrograMill C17 block, IPS e.max ZirCAD for PrograMill B45 block, Telio CAD for PrograMill B40L 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, Liquid Strip, 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 |
|---|---|---|---|---|---|---|
| Unit of Use | DIVO690811AL0 | HIBCC | ||||
| Primary | DIVO690811AL1 | HIBCC |