Aelite LS Posterior H-722A2

GUDID 20810111541866

Aelite LS Posterior A2 15ct Unit Dose (0.25g ea)

BISCO INC.

Dental composite resin
Primary Device ID20810111541866
NIH Device Record Key67af0e19-0670-4274-b520-31d2c8cc095a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAelite LS Posterior
Version Model NumberH-722A2
Catalog NumberH-722A2
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111541862 [Unit of Use]
GS110810111541869 [Primary]
GS120810111541866 [Package]
Contains: 10810111541869
Package: Item No: H-722A2P [1 Units]
In Commercial Distribution
HIBCCD757H722A20 [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 Date2022-10-18
Device Publish Date2022-10-10

On-Brand Devices [Aelite LS Posterior]

D757H722B1P1Aelite LS Posterior B1 15ct Unit Dose (0.25g ea) Pkg
D757H722A3P1Aelite LS Posterior A3 15ct Unit Dose (0.25g ea) Pkg
D757H722A35P1Aelite LS Posterior A3.5 15ct Unit Dose (0.25g ea) Pkg
D757H722A30Aelite LS Posterior A3 15ct Unit Dose (0.25g ea)
D757H722A2P1Aelite LS Posterior A2 15ct Unit Dose (0.25g ea) Pkg
D757H722A1P1Aelite LS Posterior A1 15ct Unit Dose (0.25g ea)
D757H721B1P1Aelite LS Posterior B1 4g Syringe Pkg
D757H721B10Aelite LS Posterior B1 4g Syringe
D757H721A3P1Aelite LS Posterior A3 4g Syringe Pkg
D757H721A35P1Aelite LS Posterior A3.5 4g Syringe Pkg
D757H721A350Aelite LS Posterior A3.5 4g Syringe
D757H721A30Aelite LS Posterior A3 4g Syringe
D757H721A2P1Aelite LS Posterior A2 4g Syringe Pkg
D757H721A20Aelite LS Posterior A2 4g Syringe
D757H721A1P1Aelite LS Posterior A1 4g Syringe Pkg
D757H721A10Aelite LS Posterior A1 4g Syringe
D757H722B10Aelite LS Posterior B1 15ct Unit Dose (0.25g ea)
D757H722A350Aelite LS Posterior A3.5 15ct Unit Dose (0.25g ea)
D757H722A20Aelite LS Posterior A2 15ct Unit Dose (0.25g ea)
D757H722A10Aelite LS Posterior A1 15ct Unit Dose (0.25g ea)
10810111541807Aelite LS Posterior A1 4g Syringe
10810111541814Aelite LS Posterior A2 4g Syringe
20810111541866Aelite LS Posterior A2 15ct Unit Dose (0.25g ea)
10810111541845Aelite LS Posterior B1 4g Syringe
10810111541838Aelite LS Posterior A3.5 4g Syringe
10810111541821Aelite LS Posterior A3 4g Syringe
20810111541873Aelite LS Posterior A3 15ct Unit Dose (0.25g ea)

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