FDA UDI
In Commercial Distribution
🇺🇸 United States
ROCK CORE
DI: 00816594021808
·
Model: 90838
·
DANVILLE MATERIALS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ROCK CORE
- Primary DI
- 00816594021808
- Version / Model
- 90838
- Catalog Number
- 90838
- Company Name
- DANVILLE MATERIALS, LLC
- Labeler DUNS
- 601302743
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8ef6d55c-da60-40cd-81a8-fad229493f7a
Device Description
ROCK CORE,25ML,KIT,WHITE
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
- Yes
- 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 |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16725 | Self-cured dental restorative composite resin | A dental restorative material consisting of a blend of glass or ceramic particles dispersed in a synthetic, self-polymerizable, organic resin matrix that is typically used to fill dental cavities or restore damaged dental tissue. It is typically a two-paste system (self-cured when put together) consisting basically of a dimethacrylate resin [(e.g., a bisphenol A and glycidylmethacrylate (BIS-GMA)]; the filler is usually made of glass, quartz, or ceramic. Typically, one paste contains an accelerator and the other a catalyst which polymerize a solid resin. This single-use product should match the colour of the original teeth for aesthetic reasons. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816594021808 | GS1 |
Customer Contacts
- Phone
- +1(760)743-7744 ext. 145
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 74 Degrees Fahrenheit