FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ceraMotion®
DI: J011250272010
·
Model: 250-272-01
·
DENTAURUM GmbH & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ceraMotion®
- Primary DI
- J011250272010
- Version / Model
- 250-272-01
- Company Name
- DENTAURUM GmbH & Co.KG
- Labeler DUNS
- 315427286
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-10
- Public Version
- 2
- Public Version Date
- 2022-10-13
- Public Version Status
- Update
- Public Device Record Key
- f887bd3d-bf5e-4534-8d9d-93062d4418c5
- Distribution End Date
- 2022-10-13
Device Description
ceraMotion® Paste Glaze bright, 1g / dental ceramic material
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
- 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 |
|---|---|---|---|---|---|---|
| Primary | J011250272010 | HIBCC |
Customer Contacts
- Phone
- +1(800)523-3946
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011425 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required