GC Initial™ 876558
GUDID 09010782000410
Initial LRF block A2-HT-14 ,Universal
Gc America Inc.
Dental appliance fabrication material, ceramic| Primary Device ID | 09010782000410 |
| NIH Device Record Key | 458c7fee-3490-4487-a5c8-7103f47d6235 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GC Initial™ |
| Version Model Number | 876558 |
| Catalog Number | 876558 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09010782000410 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152274
FDA Product Code
| EIH | POWDER, PORCELAIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-19 |
| Device Publish Date | 2022-10-11 |
On-Brand Devices [GC Initial™]
| J0228770181 | GC Initial™ PC Starter Package, Press pellets (20 x 5 pcs), dentin A1, A2, A3, A3.5, B2, B3, B |
| J0228720551 | GC Initial™ PC Pellets Opaque Op-5, 5pcs. X 2 |
| J0228720541 | GC Initial™ PC Pellets Opaque Op-4, 5pcs. X 2 |
| J0228720531 | GC Initial™ PC Pellets Opaque Op-3, 5pcs. X 2 |
| J0228720521 | GC Initial™ PC Pellets Opaque Op-2, 5pcs. X 2 |
| J0228720511 | GC Initial™ PC Pellets Opaque Op-1, 5pcs. X 2 |
| J0228720441 | GC Initial™ PC Pellets Occlusal OM-4, 5pcs. X 2 |
| J0228720431 | GC Initial™ PC Pellets Occlusal OM-3, 5pcs. X 2 |
| J0228720421 | GC Initial™ PC Pellets Occlusal OM-2, 5pcs. X 2 |
| J0228720411 | GC Initial™ PC Pellets Occlusal OM-1, 5pcs. X 2 |
| J0228720341 | GC Initial™ PC Pellets Occlusal OL-4, 5pcs. X 2 |
| J0228720331 | GC Initial™ PC Pellets Occlusal OL-3, 5pcs. X 2 |
| J0228720321 | GC Initial™ PC Pellets Occlusal OL-2, 5pcs. X 2 |
| J0228720311 | GC Initial™ PC Pellets Occlusal OL-1, 5pcs. X 2 |
| J0228720291 | GC Initial™ PC Pellets Transl. TY, 5pcs. X 2 |
| J0228720281 | GC Initial™ PC Pellets Transl. TN, 5pcs. X 2 |
| J0228720271 | GC Initial™ PC Pellets Transl. TD-2, 5pcs. X 2 |
| J0228720261 | GC Initial™ PC Pellets Transl. TD-1, 5pcs. X 2 |
| J0228720231 | GC Initial™ PC Pellets Veneer VE-3, 5pcs. X 2 |
| J0228720221 | GC Initial™ PC Pellets Veneer VE-2, 5pcs. X 2 |
| J0228720211 | GC Initial™ PC Pellets Veneer VE-1, 5pcs. X 2 |
| J0228720201 | GC Initial™ PC Pellets Bleached BO+, 5pcs. X 2 |
| J0228720191 | GC Initial™ PC Pellets Bleached BO, 5pcs. X 2 |
| J0228720181 | GC Initial™ PC Pellets Bleached AO+, 5pcs. X 2 |
| J0228720171 | GC Initial™ PC Pellets Bleached AO, 5pcs. X 2 |
| J0228720161 | GC Initial™ PC Pellets Dentin D4, 5pcs. X 2 |
| J0228720151 | GC Initial™ PC Pellets Dentin D3, 5pcs. X 2 |
| J0228720141 | GC Initial™ PC Pellets Dentin D2, 5pcs. X 2 |
| J0228720131 | GC Initial™ PC Pellets Dentin C4, 5pcs. X 2 |
| J0228720121 | GC Initial™ PC Pellets Dentin C3, 5pcs. X 2 |
| J0228720111 | GC Initial™ PC Pellets Dentin C2, 5pcs. X 2 |
| J0228720101 | GC Initial™ PC Pellets Dentin C1, 5pcs. X 2 |
| J0228720091 | GC Initial™ PC Pellets Dentin B4, 5pcs. X 2 |
| J0228720081 | GC Initial™ PC Pellets Dentin B3, 5pcs. X 2 |
| J0228720071 | GC Initial™ PC Pellets Dentin B2, 5pcs. X 2 |
| J0228720061 | GC Initial™ PC Pellets Dentin B1, 5pcs. X 2 |
| J0228720051 | GC Initial™ PC Pellets Dentin A4, 5pcs. X 2 |
| J0228720041 | GC Initial™ PC Pellets Dentin A3.5, 5pcs. X 2 |
| J0228720031 | GC Initial™ PC Pellets Dentin A3, 5pcs. X 2 |
| J0228720021 | GC Initial™ PC Pellets Dentin A2, 5pcs. X 2 |
| J0228720011 | GC Initial™ PC Pellets Dentin A1, 5pcs. X 2g |
| D0470128564 | GC Initial™ LiSi Press Ingot LT-B4 |
| D0470128454 | GC Initial™ LiSi Press Ingot LT-B3 |
| D0470128424 | GC Initial™ LiSi Press Ingot LT-A4 |
| D0470128414 | GC Initial™ LiSi Press Ingot LT-A3.5 (3gx5) |
| D0470128364 | GC Initial™ LiSi Press Ingot LT-B0+ (3gx5) |
| J0228770941 | GC Initial™ Spectrum Stain Set, 16 GC Initial Spectrum Stain SPS1 -SPS16, 1 GC Initial Spectru |
| J0228764271 | GC Initial™ IQ, One Body, LP NF, Enamel Effect Shade 10 - Twilight, 4g, L-10 |
| J0228764261 | GC Initial™ IQ, One Body, LP NF, Enamel Effect Shade 9 - Orange, 4g, L-9 |
| J0228761821 | GC Initial™ Spectrum Glaze Paste Liquid, 8ml |
Trademark Results [GC Initial]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC INITIAL 87258905 not registered Live/Pending |
TRADEMARK HOLDINGS OF ILLINOIS LLC 2016-12-06 |
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