FDA UDI
In Commercial Distribution
🇺🇸 United States
VITA VIONIC BASE DISC HI
DI: EDDIADSOP98301
·
Model: soft pink Ø98.5xh30mm
·
Dental Direkt GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VITA VIONIC BASE DISC HI
- Primary DI
- EDDIADSOP98301
- Version / Model
- soft pink Ø98.5xh30mm
- Catalog Number
- ADSOP9830
- Company Name
- Dental Direkt GmbH
- Labeler DUNS
- 313214171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-27
- Public Version
- 2
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- 3fbcf84b-77ec-4852-b8a0-757195958247
Device Description
VITA VIONIC BASE DISC HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. VITA VIONIC BASE DISC HI is suitable for longterm use in the oral cavity up to 10 years.
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 |
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 | EDDIADSOP98301 | HIBCC |
Customer Contacts
- Phone
- +495225863190
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230410 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 30 | Millimeter | |
| Outer Diameter | 98.5 | Millimeter |