FDA UDI
In Commercial Distribution
🇺🇸 United States
JUVORA™ Oyster White Dental Disc
DI: 05055948229629
·
Model: 540104
·
JUVORA LIMITED
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JUVORA™ Oyster White Dental Disc
- Primary DI
- 05055948229629
- Version / Model
- 540104
- Company Name
- JUVORA LIMITED
- Labeler DUNS
- 218501322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-21
- Public Version
- 1
- Public Version Date
- 2019-02-21
- Public Version Status
- New
- Public Device Record Key
- dc176cc7-fc98-4121-aef6-120504cf26ba
Device Description
JUVORA™ Oyster White Dental Disc - 98mm x 18mm 1 unit
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
- Yes
- 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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58288 | Dental appliance fabrication material, thermoplastic | A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055948229629 | GS1 |
Customer Contacts
- Phone
- +4401253898000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181331 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 18 | Millimeter | |
| Outer Diameter | 98 | Millimeter |