Aelite Aesthetic Enamel H-854CL

GUDID 20810111541675

Aelite Aesthetic Enamel Incisal Clear 15ct Unit Dose (0.25g ea)

BISCO INC.

Dental composite resin
Primary Device ID20810111541675
NIH Device Record Key7296ef0c-f495-4640-9839-ff236b3098bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAelite Aesthetic Enamel
Version Model NumberH-854CL
Catalog NumberH-854CL
Company DUNS053529939
Company NameBISCO INC.
Device Count15
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(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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111541671 [Unit of Use]
GS110810111541678 [Primary]
GS120810111541675 [Package]
Contains: 10810111541678
Package: Item No: H-854CLP [1 Units]
In Commercial Distribution
HIBCCD757H854CL0 [Previous]

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 Date2022-10-21
Device Publish Date2022-10-13

On-Brand Devices [Aelite Aesthetic Enamel]

D757H854W2P1Aelite Aesthetic Enamel Bleach W-E 15ct Unit Dose (0.25g ea) Pkg
D757H854W20Aelite Aesthetic Enamel Bleach W-E 15ct Unit Dose (0.25g ea)
D757H854FRP1Aelite Aesthetic Enamel Incisal Frost 15ct Unit Dose (0.25g ea) Pkg
D757H854FR0Aelite Aesthetic Enamel Incisal Frost 15ct Unit Dose (0.25g ea)
D757H854D4P1Aelite Aesthetic Enamel D4 15ct Unit Dose (0.25g ea) Pkg
D757H854D40Aelite Aesthetic Enamel D4 15ct Unit Dose (0.25g ea)
D757H854D2P1Aelite Aesthetic Enamel D2 15ct Unit Dose (0.25g ea) Pkg
D757H854D20Aelite Aesthetic Enamel D2 15ct Unit Dose (0.25g ea)
D757H854CLP1Aelite Aesthetic Enamel Incisal Clear 15ct Unit Dose (0.25g ea) Pkg
D757H854CL0Aelite Aesthetic Enamel Incisal Clear 15ct Unit Dose (0.25g ea)
D757H854B4P1Aelite Aesthetic Enamel B4 15ct Unit Dose (0.25g ea) Pkg
D757H854B40Aelite Aesthetic Enamel B4 15ct Unit Dose (0.25g ea)
D757H854B3P1Aelite Aesthetic Enamel B3 15ct Unit Dose (0.25g ea) Pkg
D757H854B30Aelite Aesthetic Enamel B3 15ct Unit Dose (0.25g ea)
D757H854B2P1Aelite Aesthetic Enamel B2 15ct Unit Dose (0.25g ea) Pkg
D757H854B20Aelite Aesthetic Enamel B2 15ct Unit Dose (0.25g ea)
D757H854B1P1Aelite Aesthetic Enamel B1 15ct Unit Dose (0.25g ea) Pkg
D757H854B10Aelite Aesthetic Enamel B1 15ct Unit Dose (0.25g ea)
D757H854A4P1Aelite Aesthetic Enamel A4 15ct Unit Dose (0.25g ea) Pkg
D757H854A40Aelite Aesthetic Enamel A4 15ct Unit Dose (0.25g ea)
D757H854A3P1Aelite Aesthetic Enamel A3 15ct Unit Dose (0.25g ea) Pkg
D757H854A35P1Aelite Aesthetic Enamel A3.5 15ct Unit Dose (0.25g ea) Pkg
D757H854A350Aelite Aesthetic Enamel A3.5 15ct Unit Dose (0.25g ea)
D757H854A30Aelite Aesthetic Enamel A3 15ct Unit Dose (0.25g ea)
D757H854A2P1Aelite Aesthetic Enamel A2 15ct Unit Dose (0.25g ea) Pkg
D757H854A20Aelite Aesthetic Enamel A2 15ct Unit Dose (0.25g ea)
D757H854A1P1Aelite Aesthetic Enamel A1 15ct Unit Dose (0.25g ea) Pkg
D757H854A10Aelite Aesthetic Enamel A1 15ct Unit Dose (0.25g ea)
D757H852W2P1Aelite Aesthetic Enamel Bleach W-E Syringe Pkg
D757H852W20Aelite Aesthetic Enamel Bleach W-E Syringe
D757H852FRP1Aelite Aesthetic Enamel Incisal Frost Syringe Pkg
D757H852FR0Aelite Aesthetic Enamel Incisal Frost Syringe
D757H852D4P1Aelite Aesthetic Enamel D4 Syringe Pkg
D757H852D40Aelite Aesthetic Enamel D4 Syringe
D757H852D2P1Aelite Aesthetic Enamel D2 Syringe Pkg
D757H852D20Aelite Aesthetic Enamel D2 Syringe
D757H852CLP1Aelite Aesthetic Enamel Incisal Clear Syringe Pkg
D757H852CL0Aelite Aesthetic Enamel Incisal Clear Syringe
D757H852B4P1Aelite Aesthetic Enamel B4 Syringe Pkg
D757H852B40Aelite Aesthetic Enamel B4 Syringe
D757H852B3P1Aelite Aesthetic Enamel B3 Syringe Pkg
D757H852B30Aelite Aesthetic Enamel B3 Syringe
D757H852B2P1Aelite Aesthetic Enamel B2 Syringe Pkg
D757H852B20Aelite Aesthetic Enamel B2 Syringe
D757H852B1P1Aelite Aesthetic Enamel B1 Syringe Pkg
D757H852B10Aelite Aesthetic Enamel B1 Syringe
D757H852A4P1Aelite Aesthetic Enamel A4 Syringe Pkg
D757H852A40Aelite Aesthetic Enamel A4 Syringe
D757H852A3P1Aelite Aesthetic Enamel A3 Syringe Pkg
D757H852A35P1Aelite Aesthetic Enamel A3.5 Syringe Pkg
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