Image Tooth Shade Acry 2282583

GUDID 00304040001004

Image Tooth Shade Acry

HENRY SCHEIN, INC.

Dental crown/bridge resin, temporary
Primary Device ID00304040001004
NIH Device Record Key56c49a9a-83bf-4336-a129-12ef64b85a51
Commercial Distribution StatusIn Commercial Distribution
Brand NameImage Tooth Shade Acry
Version Model Number2282583
Catalog Number2282583
Company DUNS012430880
Company NameHENRY SCHEIN, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Weight125 Gram
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram
Device Size Text, specify0
Weight125 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product at room temperature, in a cool area.

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040001004 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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