FDA UDI
In Commercial Distribution
🇺🇸 United States
Cavex Instant Stone
DI: E241VT0120
·
Model: VT012
·
Cavex Holland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cavex Instant Stone
- Primary DI
- E241VT0120
- Version / Model
- VT012
- Catalog Number
- VT012
- Company Name
- Cavex Holland B.V.
- Labeler DUNS
- 419980156
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-10
- Public Version
- 1
- Public Version Date
- 2026-03-18
- Public Version Status
- New
- Public Device Record Key
- b7e60b20-3c13-4660-b276-eb130f1fdfb2
Device Description
Cavex Instant Stone + Activator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PZY | Additively Manufactured, Preformed, Resin Denture Tooth | Dental | 872.3590 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35909 | Dental casting investment material | A material consisting mainly of a suitable allotrope of silica (to give a desired thermal expansion) and a bonding material, used in the dental laboratory to form the mould for dental castings. The bonding material may be either gypsum, phosphates, or silicates. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E241VT0120 | HIBCC |
Customer Contacts
- Phone
- 0235307725
- [email protected]