FDA UDI
Not in Commercial Distribution
🇺🇸 United States
inCoris & CEREC
DI: E27665357560
·
Model: 6535756
·
SIRONA Dental Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- inCoris & CEREC
- Primary DI
- E27665357560
- Version / Model
- 6535756
- Company Name
- SIRONA Dental Systems GmbH
- Labeler DUNS
- 340306351
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- 0885902d-cb7c-46e0-ada4-11ea6940c427
- Distribution End Date
- 2023-10-13
Device Description
inCoris Intro-Kit N consists of 1 pcs of: 6135458 BLOCK 40/15 ZI F2 6135854 BLOCK 40/19 ZI F2 6122753 BLOCK 40/19 ZI F0.5 6339456 Block inCoris TZI 40/19 6605773 CEREC Blocs C In BL2 6449990 CEREC Blocs C In A1 6605781 CEREC Blocs C In A2 6605799 CEREC Blocs C In A3 6605807 CEREC Blocs C In A3,5 6605815 CEREC Blocs C In A4 6480433 Block inCoris TZI C mono L 20/19 A1 6480441 Block inCoris TZI C mono L 20/19 A2 6480458 Block inCoris TZI C mono L 20/19 A3 6480466 Block inCoris TZI C mono L 20/19 A3,5 6480474 Block inCoris TZI C mono L 20/19 A4
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 | E27665357560 | HIBCC |
Customer Contacts
- Phone
- +4962511670
- [email protected]