FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxford Cal VLC
DI: EFSM230010
·
Model: 23-001
·
First Scientific Dental Materials GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Oxford Cal VLC
- Primary DI
- EFSM230010
- Version / Model
- 23-001
- Company Name
- First Scientific Dental Materials GmbH
- Labeler DUNS
- 341553292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2020-09-06
- Public Version
- 1
- Public Version Date
- 2020-09-14
- Public Version Status
- New
- Public Device Record Key
- ebc48512-4523-406f-941d-b340b0445c09
Device Description
Light Cure Calcium Hydroxide Liner
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 |
|---|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | 872.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62199 | Calcium hydroxide dental cement | A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. 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 | EFSM230010 | HIBCC | ||||
| Unit of Use | E23001 | HIBCC |
Customer Contacts
- Phone
- +4904121909508
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius