GC Initial™ 012931

GUDID D0470129310

Initial LiSi Block 14 CEREC A1 LT 5p

Gc America Inc.

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic
Primary Device IDD0470129310
NIH Device Record Key59867d8e-7d45-49dc-95bb-e469fc648487
Commercial Distribution StatusIn Commercial Distribution
Brand NameGC Initial™
Version Model Number012931
Catalog Number012931
Company DUNS005473608
Company NameGc America Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0470129310 [Unit of Use]
HIBCCD0470129311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPOWDER, PORCELAIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-13
Device Publish Date2021-10-05

On-Brand Devices [GC Initial™]

J0228770181GC Initial™ PC Starter Package, Press pellets (20 x 5 pcs), dentin A1, A2, A3, A3.5, B2, B3, B
J0228720551GC Initial™ PC Pellets Opaque Op-5, 5pcs. X 2
J0228720541GC Initial™ PC Pellets Opaque Op-4, 5pcs. X 2
J0228720531GC Initial™ PC Pellets Opaque Op-3, 5pcs. X 2
J0228720521GC Initial™ PC Pellets Opaque Op-2, 5pcs. X 2
J0228720511GC Initial™ PC Pellets Opaque Op-1, 5pcs. X 2
J0228720441GC Initial™ PC Pellets Occlusal OM-4, 5pcs. X 2
J0228720431GC Initial™ PC Pellets Occlusal OM-3, 5pcs. X 2
J0228720421GC Initial™ PC Pellets Occlusal OM-2, 5pcs. X 2
J0228720411GC Initial™ PC Pellets Occlusal OM-1, 5pcs. X 2
J0228720341GC Initial™ PC Pellets Occlusal OL-4, 5pcs. X 2
J0228720331GC Initial™ PC Pellets Occlusal OL-3, 5pcs. X 2
J0228720321GC Initial™ PC Pellets Occlusal OL-2, 5pcs. X 2
J0228720311GC Initial™ PC Pellets Occlusal OL-1, 5pcs. X 2
J0228720291GC Initial™ PC Pellets Transl. TY, 5pcs. X 2
J0228720281GC Initial™ PC Pellets Transl. TN, 5pcs. X 2
J0228720271GC Initial™ PC Pellets Transl. TD-2, 5pcs. X 2
J0228720261GC Initial™ PC Pellets Transl. TD-1, 5pcs. X 2
J0228720231GC Initial™ PC Pellets Veneer VE-3, 5pcs. X 2
J0228720221GC Initial™ PC Pellets Veneer VE-2, 5pcs. X 2
J0228720211GC Initial™ PC Pellets Veneer VE-1, 5pcs. X 2
J0228720201GC Initial™ PC Pellets Bleached BO+, 5pcs. X 2
J0228720191GC Initial™ PC Pellets Bleached BO, 5pcs. X 2
J0228720181GC Initial™ PC Pellets Bleached AO+, 5pcs. X 2
J0228720171GC Initial™ PC Pellets Bleached AO, 5pcs. X 2
J0228720161GC Initial™ PC Pellets Dentin D4, 5pcs. X 2
J0228720151GC Initial™ PC Pellets Dentin D3, 5pcs. X 2
J0228720141GC Initial™ PC Pellets Dentin D2, 5pcs. X 2
J0228720131GC Initial™ PC Pellets Dentin C4, 5pcs. X 2
J0228720121GC Initial™ PC Pellets Dentin C3, 5pcs. X 2
J0228720111GC Initial™ PC Pellets Dentin C2, 5pcs. X 2
J0228720101GC Initial™ PC Pellets Dentin C1, 5pcs. X 2
J0228720091GC Initial™ PC Pellets Dentin B4, 5pcs. X 2
J0228720081GC Initial™ PC Pellets Dentin B3, 5pcs. X 2
J0228720071GC Initial™ PC Pellets Dentin B2, 5pcs. X 2
J0228720061GC Initial™ PC Pellets Dentin B1, 5pcs. X 2
J0228720051GC Initial™ PC Pellets Dentin A4, 5pcs. X 2
J0228720041GC Initial™ PC Pellets Dentin A3.5, 5pcs. X 2
J0228720031GC Initial™ PC Pellets Dentin A3, 5pcs. X 2
J0228720021GC Initial™ PC Pellets Dentin A2, 5pcs. X 2
J0228720011GC Initial™ PC Pellets Dentin A1, 5pcs. X 2g
D0470128564GC Initial™ LiSi Press Ingot LT-B4
D0470128454GC Initial™ LiSi Press Ingot LT-B3
D0470128424GC Initial™ LiSi Press Ingot LT-A4
D0470128414GC Initial™ LiSi Press Ingot LT-A3.5 (3gx5)
D0470128364GC Initial™ LiSi Press Ingot LT-B0+ (3gx5)
J0228770941GC Initial™ Spectrum Stain Set, 16 GC Initial Spectrum Stain SPS1 -SPS16, 1 GC Initial Spectru
J0228764271GC Initial™ IQ, One Body, LP NF, Enamel Effect Shade 10 - Twilight, 4g, L-10
J0228764261GC Initial™ IQ, One Body, LP NF, Enamel Effect Shade 9 - Orange, 4g, L-9
J0228761821GC Initial™ Spectrum Glaze Paste Liquid, 8ml

Trademark Results [GC Initial]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GC INITIAL
GC INITIAL
87258905 not registered Live/Pending
TRADEMARK HOLDINGS OF ILLINOIS LLC
2016-12-06

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