CERASMART® 011959

GUDID D0470119591

CERASMART® Glidewell 14 B1 LT 5p Block

Gc America Inc.

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Primary Device IDD0470119591
NIH Device Record Keyc57e5a0c-b4fa-46be-be94-82ce71d6940f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCERASMART®
Version Model Number011959
Catalog Number011959
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0470119590 [Unit of Use]
HIBCCD0470119591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-10-16

On-Brand Devices [CERASMART®]

D0470119601CERASMART® Glidewell 14 Bleach 5p Block
D0470119591CERASMART® Glidewell 14 B1 LT 5p Block
D0470119581CERASMART® Glidewell 14 A3.5 LT 5p Block
D0470119571CERASMART® Glidewell 14 A3 LT 5p Block
D0470119561CERASMART® Glidewell 14 A2 LT 5p Block
D0470119551CERASMART® Glidewell 14 A1 LT 5p Block
D0470119541CERASMART® Glidewell 14 B1 HT 5p Block
D0470119531CERASMART® Glidewell 14 A3.5 HT 5p Block
D0470119521CERASMART® Glidewell 14 A3 HT 5p Block
D0470119511CERASMART® Glidewell 14 A2 HT 5p Block
D0470119501CERASMART® Glidewell 14 A1 HT 5p Block
D0470086852CERASMART® Universal (Size 14L), Shade Bleach, 5 pieces
D0470086842CERASMART® Universal (Size 14L), B1 Low Translucency, 5 pieces
D0470086832CERASMART® Universal (Size 14L), A3.5 LowTranslucency, 5 pieces
D0470086822CERASMART® Universal (Size 14L), A3 Low Translucency, 5 pieces
D0470086812CERASMART® Universal (Size 14L), A2 Low Translucency, 5 pieces
D0470086802CERASMART® Universal (Size 14L), A1 Low Translucency, 5 pieces
D0470086792CERASMART® Universal (Size 14L), B1 High Translucency, 5 pieces
D0470086782CERASMART® Universal (Size 14L), A3.5 High Translucency, 5 pieces
D0470086772CERASMART® Universal (Size 14L), A3 High Translucency, 5 pieces
D0470086762CERASMART® Universal (Size 14L), A2 HighTranslucency, 5 pieces
D0470086752CERASMART® Universal (Size 14L), A1 High Translucency, 5 pieces
D0470086742CERASMART® Universal (Size 14), BL Shade Bleach, 5 pieces
D0470086732CERASMART® Universal (Size 14), B1 Low Translucency, 5 pieces
D0470086722CERASMART® Universal (Size 14), A3.5 Low Translucency, 5 pieces
D0470086712CERASMART® Universal (Size 14), A3 Low Translucency, 5 pieces
D0470086702CERASMART® Universal (Size 14), A2 Low Translucency, 5 pieces
D0470086692CERASMART® Universal (Size 14), A1 Low Translucency, 5 pieces
D0470086682CERASMART® Universal (Size 14), B1 High Translucency, 5 pieces
D0470086672CERASMART® Universal (Size 14), A3.5 High Translucency, 5 pieces
D0470086662CERASMART® Universal (Size 14), A3 High Translucency , 5 pieces
D0470086652CERASMART® Universal (Size 14), A2 High Translucency, 5 pieces
D0470086642CERASMART® Universal (Size 14), A1 High Translucency, 5 pieces
D0470086632CERASMART® Universal (Size 12), BL Shade Bleach, 5 pieces
D0470086622CERASMART® Universal (Size 12), B1 Low Translucency, 5 pieces
D0470086612CERASMART® Universal (Size 12), A3.5 Low Translucency, 5 pieces
D0470086602CERASMART® Universal (Size 12), A3 Low Translucency, 5 pieces
D0470086592CERASMART® Universal (Size 12), A2 Low Translucency, 5 pieces
D0470086582CERASMART® Universal (Size 12), A1 Low Translucency, 5 pieces
D0470086572CERASMART® Universal (Size 12), B1 High Translucency, 5 pieces
D0470086562CERASMART® Universal (size 12), A3.5 High Translucency, 5 pieces
D0470086552CERASMART® Universal (Size 12), A3 High Translucency, 5 pieces
D0470086542CERASMART® Universal (Size 12), A2 High Translucency, 5 pieces
D0470086532CERASMART® Universal (Size 12), A1 High Translucency, 5 pieces
D0470084072CERASMART® for Planmill 14L Bleach 5 pieces
D0470084062CERASMART® for Planmill 14L B1LT 5 pieces
D0470084052CERASMART® for Planmill 14L A3.5LT 5 pieces
D0470084042CERASMART® for Planmill 14L A3 LT 5 pieces
D0470084032CERASMART® for Planmill 14L A2 LT 5 pieces
D0470084022CERASMART® for Planmill 14L A1 LT 5 pieces

Trademark Results [CERASMART]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CERASMART
CERASMART
86333135 4783289 Live/Registered
GC CORPORATION
2014-07-10
CERASMART
CERASMART
86141651 4704933 Live/Registered
GC CORPORATION
2013-12-12

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