FDA UDI
In Commercial Distribution
🇺🇸 United States
GrandioSO x-tra
DI: E22127161
·
Model: 2716
·
VOCO GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
16
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Basic Information
- Brand Name
- GrandioSO x-tra
- Primary DI
- E22127161
- Version / Model
- 2716
- Catalog Number
- 2716
- Company Name
- VOCO GmbH
- Labeler DUNS
- 316699578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 16
- Record Status
- Published
- Publish Date
- 2018-08-29
- Public Version
- 1
- Public Version Date
- 2018-10-01
- Public Version Status
- New
- Public Device Record Key
- 2822c2cd-5df4-4363-bf7c-cd2375783899
Device Description
GrandioSO x-tra Caps 16x0.25g A2 GrandiSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterized by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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 | E22127161 | HIBCC | ||||
| Unit of Use | E22127160 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 23 Degrees Celsius