AELITE LS A2 15tips/Fex Tube H-722A2F

GUDID D757H722A2F0

BISCO INC.

Dental composite resin
Primary Device IDD757H722A2F0
NIH Device Record Key20b3f3a1-6cb9-47d1-b68c-26b85d5de8dc
Commercial Distribution Discontinuation2019-12-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAELITE LS A2 15tips/Fex Tube
Version Model NumberH-722A2F
Catalog NumberH-722A2F
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 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

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD757H722A2F0 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-06
Device Publish Date2017-06-12

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