FDA UDI
In Commercial Distribution
🇺🇸 United States
GC Initial™
DI: EKLE8765121
·
Model: 876512
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- GC Initial™
- Primary DI
- EKLE8765121
- Version / Model
- 876512
- Catalog Number
- 876512
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-10-16
- Public Version
- 4
- Public Version Date
- 2018-07-24
- Public Version Status
- Update
- Public Device Record Key
- 4c5f3979-2491-49f1-b10e-dffd8b4fbb0d
Device Description
Initial LRF block A2-LT-14L ,Cerec
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| EIH | POWDER, PORCELAIN | Dental | 872.6660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16187 | Dental appliance fabrication material, ceramic | A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EKLE8765121 | HIBCC | ||||
| Unit of Use | EKLE8765120 | HIBCC |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152274 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius