FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GC Initial™
DI: J0228770081
·
Model: 877008
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GC Initial™
- Primary DI
- J0228770081
- Version / Model
- 877008
- Catalog Number
- 877008
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 4
- Public Version Date
- 2018-07-24
- Public Version Status
- Update
- Public Device Record Key
- 03bbebc6-d7a6-487e-b0a8-b16a199156c0
- Distribution End Date
- 2016-08-01
Device Description
GC Initial™ AL Basic Set, AL Liner 6, Dentin 16, Opaqus Dentin Modifier 2, Enamel 4, Enamel Intensive 4, Clear Fluorescence 1, Translucent 2, Translucent Modifier 5, Glaze (10g) 1, Incisio (3g) 1, liquids 25mL Glaze Liquid, 50mL Modeling Liquid
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 | J0228770081 | HIBCC |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040567 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 813 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius