FDA UDI
In Commercial Distribution
🇺🇸 United States
Ortho Veneer System
DI: D798OVS0
·
Model: OVS
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ortho Veneer System
- Primary DI
- D798OVS0
- Version / Model
- OVS
- Catalog Number
- OVS
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-17
- Public Version
- 5
- Public Version Date
- 2020-07-24
- Public Version Status
- Update
- Public Device Record Key
- cb484a44-ebd5-4208-8022-a84f2e0e1ee1
Device Description
OVS is intended for use as a composite system for the fabrication of veneers on undersized teeth. The kit contains 1 X 3cc Light Bond Sealant, 1 X 2.5g Ortho Veneer paste shade B-1, 1 X 2.5g Ortho Veneer shade A-1, 1 X 2.5g Ortho Veneer shade A-2, (5 Medium and 5 Large) Faci Forms Crown Form #12, (5 Medium and 5 Large) Faci Forms Crown Form #22, 1 X (16) Stick and Place instruments
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47906 | Custom-made dental composite resin kit | A collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D798OVS0 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature (15-30 Degrees C)