FDA UDI
In Commercial Distribution
🇺🇸 United States
CEREC® Essentials featuring Zirconia Translucent Zirconium Oxice Blocks
DI: D00261N0011
·
Model: 61N001
·
DENTSPLY INTERNATIONAL INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CEREC® Essentials featuring Zirconia Translucent Zirconium Oxice Blocks
- Primary DI
- D00261N0011
- Version / Model
- 61N001
- Catalog Number
- 61N001
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-24
- Public Version
- 1
- Public Version Date
- 2022-06-01
- Public Version Status
- New
- Public Device Record Key
- 3f8c1f73-124e-4cc2-b7c8-34104d7b62f2
Device Description
CEREC® Essentials with Zirconia Chairside Consumables Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
| EMA | CEMENT, DENTAL | Dental | 872.3275 | 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 | D00261N0011 | HIBCC |
Customer Contacts
- Phone
- +1(800)583-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12 CEREC Zirconia blocks, 2 syringes Calibra Universal Cement with 20 mix tips, 1 round dusting brush, 2 Scotch Bright brushes |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from moisture.