FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OVC3 Hybrid
DI: 09421031795306
·
Model: Professional Kit A2
·
RHONDIUM LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OVC3 Hybrid
- Primary DI
- 09421031795306
- Version / Model
- Professional Kit A2
- Catalog Number
- 9421031795306
- Company Name
- RHONDIUM LIMITED
- Labeler DUNS
- 595078345
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-03
- Public Version
- 4
- Public Version Date
- 2018-08-29
- Public Version Status
- Update
- Public Device Record Key
- cae3867e-7084-4991-95ff-22310a08be97
- Distribution End Date
- 2017-10-04
Device Description
The Professional Kit consists of 40 OVC Hybrid in tooth shade A2 - for Upper and Lower molars and premolars. Each OVC Hybrid is packaged with 2 x OVC Wedges, 2 x Stretch Wedges, a Selector Key, 1 x OVC3 Matrix Band and an OVC Hybrid Replica.
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 | 09421031795306 | GS1 |
Customer Contacts
- Phone
- 1-800-875-6246
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Extra-Small, Small, Medium, Large, Extra-Large |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 25 Degrees Celsius