FDA UDI
In Commercial Distribution
🇺🇸 United States
GC Initial™
DI: 15400556703578
·
Model: 877084
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GC Initial™
- Primary DI
- 15400556703578
- Version / Model
- 877084
- Catalog Number
- 877084
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-29
- Public Version
- 1
- Public Version Date
- 2022-08-08
- Public Version Status
- New
- Public Device Record Key
- 93b3929e-8c75-47fb-8cc5-8fec86a594fe
Device Description
GC Initial™ MC Classic Line Work Set 2, 8 paste opaque classic linPO-CL A4, B1, B4, C1, C2, C4, D2, D4 -4g, GC Initial IQ One body concept Fluo Crystals 9g, 8 dentin D-A4, B1, B4, C1, C2, C4, D2, D4-20g, 2 bleach dentin BLD-1 light, BLD-3 xwhite-20g, 8 opaque dentin OD-A4, B1, B4, C1, C2, C4, D2, D4-20g, 2 enamel E-57, 60-20g, correction powder COR (20g), paste opaque thinner 8mL, modeling liquid 50 mL.
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 |
|---|---|---|---|---|
| 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 | 15400556703578 | GS1 |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040567 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 77 Degrees Fahrenheit