FDA UDI
In Commercial Distribution
🇺🇸 United States
PS e.max Ceram
DI: DIVO681628EN1
·
Model: 681628EN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
19
Basic Information
- Brand Name
- PS e.max Ceram
- Primary DI
- DIVO681628EN1
- Version / Model
- 681628EN
- Catalog Number
- 681628EN
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 19
- Record Status
- Published
- Publish Date
- 2021-02-11
- Public Version
- 1
- Public Version Date
- 2021-02-19
- Public Version Status
- New
- Public Device Record Key
- a1228a3d-9257-484d-a1ec-358cc3d6eefe
Device Description
IPS e.max Ceram ZirLiner 5 g, 1IPS e.max C Margin A2 5 g, IPS e.max C Deep Dentin A2 5 g, IPS e.max C Dentin A2 5 g, IPS e.max C Transpa incisal 1 5 g, IPS e.max C Transpa clear 5 g, IPS e.max C Opal Effect 1 5 g, IPS e.max C Opal Effect 3 5 g, IPS e.max C Occl. Dentin orange 5 g, IPS e.max C Mamelon light 5 g, IPS Ivocolor Essence 1.8g E01 white, IPS Ivocolor Essence 1.8g E04 sunset, IPS Ivocolor Essence 1.8g E10 maho, Ivocolor Shade Dentin SD2 3g, IPS Ivocolor Glaze Powder FLUO 1.8g, IPS e.max C ZirLiner Liquid 15 ml, IPS e.max C Margin Liquid allround 15 ml, Build-Up Liquid 15ml allround, Ivocolor Mixing Liquid allround 15ml
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 | DIVO681628EN0 | HIBCC | ||||
| Primary | DIVO681628EN1 | HIBCC |