Aeliteflo H-675OW

GUDID 00810111540339

AELITEFLO L/C Composite Opaque White 1.5gm

BISCO INC.

Dental composite resin
Primary Device ID00810111540339
NIH Device Record Keyd50076aa-7a11-49e1-87c7-e4dfdd8ac6f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAeliteflo
Version Model NumberH-675OW
Catalog NumberH-675OW
Company DUNS053529939
Company NameBISCO INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111540339 [Primary]
HIBCCD757H675OW0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMATERIAL, TOOTH SHADE, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-25
Device Publish Date2022-11-17

On-Brand Devices [Aeliteflo]

D757H675TIF1AELITEFLO Composite Tran. Syr.
D757H675TI0AELITEFLO L/C Comp Tr 1.5gm
D757H675OWF1AELITEFLO Composite W-Op. Syr.
D757H675OW0AELITEFLO L/C Comp W-O 1.5gm
D757H674D3F1AELITEFLO Composite D3 Syr.
D757H674D30AELITEFLO L/C Comp D3 1.5gm
D757H673C3F1AELITEFLO Composite C3 Syr.
D757H673C30AELITEFLO L/C Comp C3 1.5gm
D757H673C2F1AELITEFLO Composite C2 Syr.
D757H673C20AELITEFLO L/C Comp C2 1.5gm
D757H672B1F1AELITEFLO Composite B1 Syr.
D757H671A5F1AELITEFLO Composite A5 Syr.
D757H671A50AELITEFLO L/C Comp A5 1.5gm
D757H671A3F1AELITEFLO Composite A3 Syr.
D757H671A35F1AELITEFLO Composite A3.5 Syr.
D757H671A350AELITEFLO L/C Comp A3.5 1.5gm
D757H671A30AELITEFLO L/C Comp A3 1.5gm
D757H671A2OF1AELITEFLO Composite A2O Syr.
D757H671A2O0AELITEFLO Composite A2O 1.5gm
D757H671A2F1AELITEFLO Composite A2 Syr.
D757H671A20AELITEFLO L/C Comp A2 1.5gm
D757H671A1F1AELITEFLO Composite A1 Syr.
D757H671A10AELITEFLO L/C Comp A1 1.5gm
D757H672B10AELITEFLO L/C Comp B1 1.5gm
00810111540209AELITEFLO Composite A3 Syr.
00810111540193AELITEFLO L/C Comp A3 1.5gm
00810111540162AELITEFLO Composite A2 Syr.
00810111540155AELITEFLO L/C Comp A2 1.5gm
00810111540148AELITEFLO Composite A1 Syr.
00810111540346AELITEFLO Composite White Opaque. Syr. Package
00810111540278AELITEFLO L/C Comp C2 1.5gm
00810111540360AELITEFLO Composite Tran. Syr.
00810111540285AELITEFLO Composite C2 Syr. Pkg
00810111540254AELITEFLO L/C Comp B1 1.5gm
00810111540223AELITEFLO Composite A3.5 Syr. Pkg
00810111540216AELITEFLO L/C Comp A3.5 1.5gm
00810111540131AELITEFLO L/C Comp A1 1.5gm
00810111540353AELITEFLO L/C Comp Tr 1.5gm
00810111540261AELITEFLO Composite B1 Syr.
00810111540179AELITEFLO Composite A2O 1.5gm
00810111540186AELITEFLO Composite A2O Syr.
00810111540339AELITEFLO L/C Composite Opaque White 1.5gm
00810111540322AELITEFLO Composite D3 Syr.
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