Amelogen Plus 8010

GUDID 00883205036957

Amelogen Plus Singles A1 10pk

ULTRADENT PRODUCTS, INC.

Dental composite resin
Primary Device ID00883205036957
NIH Device Record Key7decb9cf-75f0-4810-a531-762b71a85481
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmelogen Plus
Version Model Number8010
Catalog Number8010
Company DUNS013369913
Company NameULTRADENT PRODUCTS, 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(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205036957 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-30
Device Publish Date2023-08-22

On-Brand Devices [Amelogen Plus]

00883205107237Amelogen Plus Syringe Trans Orange Refill
00883205107220Amelogen Plus Syringe Trans Gray Refill
00883205107213Amelogen Plus Syringe Trans White Refill
00883205107206Amelogen Plus Syringe Enamel Gray Refill
00883205107190Amelogen Plus Syringe Enamel Neutral Refill
00883205107183Amelogen Plus Syringe Enamel White Refill
00883205107176Amelogen Plus Syringe Opaque White Refill
00883205107169Amelogen Plus Syringe C2 Refill
00883205107152Amelogen Plus Syringe B1 Refill
00883205107145Amelogen Plus Syringe A5 Refill
00883205107138Amelogen Plus Syringe A4 Refill
00883205107121Amelogen Plus Syringe A3 Refill
00883205107114Amelogen Plus Syringe A2 Refill
00883205107107Amelogen Plus Syringe A1 Refill
00883205107091Amelogen Plus Syringe A3.5 Refill
00883205107053Amelogen Plus Singles Super Light 10pk
00883205107046Amelogen Plus Singles A3.5 10pk
00883205107039Amelogen Plus Singles Enamel Neutral 10pk
00883205107022Amelogen Plus Singles Enamel White 10pk
00883205107015Amelogen Plus Singles Opaque White 10pk
00883205107008Amelogen Plus Singles C2 10pk
00883205106995Amelogen Plus Singles Trans Orange 10pk
00883205106988Amelogen Plus Singles Trans Gray 10pk
00883205106971Amelogen Plus Singles B1 10pk
00883205106964Amelogen Plus Singles Trans White 10pk
00883205106957Amelogen Plus Singles A5 10pk
00883205106940Amelogen Plus Singles A4 10pk
00883205106933Amelogen Plus Singles A3 10pk
00883205106926Amelogen Plus Singles Enamel Gray 10pk
00883205106919Amelogen Plus Singles A2 10pk
00883205106902Amelogen Plus Singles A1 10pk
00883205106681Amelogen Plus Singles Complete Kit
00883205106667Amelogen Plus Syringe Complete Kit
00883205106650Amelogen Plus Basic Singles Kit
00883205106612Amelogen Plus Syringe Basic Kit
00883205106544Amelogen Plus Syringe Natural Kit
00883205105516Amelogen Plus Syringe Cosmetic Kit
00883205101266AMELOGEN PLUS HANDS-ON KIT
00883205027320Amelogen Plus Syringe Cosmetic Kit
00883205027313Amelogen Plus Syringe Basic Kit
00883205037268Amelogen Plus Hands-On Kit
00883205037251Amelogen Plus Syringe Trans Orange Refill
00883205037244Amelogen Plus Syringe Trans Gray Refill
00883205037237Amelogen Plus Syringe Trans White Refill
00883205037220Amelogen Plus Syringe Enamel Gray Refill
00883205037213Amelogen Plus Syringe Enamel Neutral Refill
00883205037206Amelogen Plus Syringe Enamel White Refill
00883205037190Amelogen Plus Syringe Opaque White Refill
00883205037183Amelogen Plus Syringe C2 Refill
00883205037176Amelogen Plus Syringe B1 Refill
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