FDA UDI
In Commercial Distribution
🇺🇸 United States
Set Fresco Essential
DI: D800KEAD6391
·
Model: KEAD6391
·
ZIRKONZAHN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Set Fresco Essential
- Primary DI
- D800KEAD6391
- Version / Model
- KEAD6391
- Company Name
- ZIRKONZAHN SRL
- Labeler DUNS
- 564251911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-25
- Public Version
- 1
- Public Version Date
- 2023-03-06
- Public Version Status
- New
- Public Device Record Key
- ea2677f4-d67f-437f-a257-6fa1255ed6a5
Device Description
Content: Set Fresco Essential consisting of: 10 x ceramic pastes (Fresco Gingiva 1-6, Fresco Enamel Fluo, Opal, Transpa 3 and Transpa Neutral), 1 x Fresco gel, 1 x Fresco liquid, 1 x brush 0, 1 x brush 2, 1 x bristle paint round brush 6, 1 x spatula for ceramic Enrico Steger, 1 x glass plate Ceramic pastes for veneering slightly reduced and monolithic zirconia structures in the gingival and vestibular regions with excellent modelling properties and easy firing.
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
- Yes
- Has Expiration Date
- No
- 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 | D800KEAD6391 | HIBCC |
Customer Contacts
- Phone
- +390474066660
- [email protected]