FDA UDI
In Commercial Distribution
🇺🇸 United States
Core It White
DI: 08809262954869
·
Model: 101-0303
·
Spident Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Core It White
- Primary DI
- 08809262954869
- Version / Model
- 101-0303
- Catalog Number
- 101-0303
- Company Name
- Spident Co., Ltd.
- Labeler DUNS
- 689370711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-20
- Public Version
- 8
- Public Version Date
- 2022-08-24
- Public Version Status
- Update
- Public Device Record Key
- e37ef358-3a18-40ce-bc26-d67dc046db25
Device Description
Radiopaque, dual cured composite core build up material in white shade
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 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 | 08809262954869 | GS1 | ||||
| Package | 20200105170163 | GS1 | 70 | Not in Commercial Distribution | 2019-05-16 | |
| Package | 00202101110187 | GS1 | 100 | Not in Commercial Distribution | 2021-01-25 | |
| Package | 00000202208242 | GS1 | 70 | Not in Commercial Distribution | 2022-08-24 |
Customer Contacts
- Phone
- 201-944-0511
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092572 | 000 |