FDA UDI
In Commercial Distribution
🇺🇸 United States
ApexCal
DI: 07615208008661
·
Model: 595915AN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- ApexCal
- Primary DI
- 07615208008661
- Version / Model
- 595915AN
- Catalog Number
- 595915AN
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-08-18
- Public Version
- 3
- Public Version Date
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- f2fe16b3-0dc7-42f5-b579-60e2abbe9800
Device Description
ApexCal Refill 2x2.5 g
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
- 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 |
|---|---|---|---|---|
| EJK | LINER, CAVITY, CALCIUM HYDROXIDE | Dental | 872.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60275 | Endodontic temporary cement | A viscous material intended for the temporary obturation of a prepared root canal, to maintain relative sterility between procedures and facilitate healing. Commonly referred to as temporary filling or sealer, it is typically a zinc or calcium cement-based paste that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a prefilled tube or syringe; some types require the use of a separate sealer. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07615208433258 | GS1 | ||||
| Primary | 07615208008661 | GS1 | ||||
| Previous | DVIV595915AN1 | HIBCC |