FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OVC™ One Visit Crown
DI: 09421031790189
·
Model: OVC 14-15 XL A3
·
RHONDIUM LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OVC™ One Visit Crown
- Primary DI
- 09421031790189
- Version / Model
- OVC 14-15 XL A3
- Company Name
- RHONDIUM LIMITED
- Labeler DUNS
- 595078345
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2018-11-26
- Public Version Status
- Update
- Public Device Record Key
- 8e5cc681-7a11-426d-a6cf-d35e3a485d44
- Distribution End Date
- 2017-09-01
Device Description
Package contains an OVC for tooth number 14 or 15, in shade A3 and size XL (extra large), 4 x OVC wedges, a selector key and an OVC 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 |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61718 | Preformed dental crown, permanent | A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure (e.g. disposable prosthesis gauge). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421031790189 | GS1 |
Customer Contacts
- Phone
- 1-800-875-6246
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143694 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Extra Large |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 25 Degrees Celsius