Ultra-Blend Plus 1016

GUDID 00883205104038

Ultra-Blend Plus Mini Kit Universal

ULTRADENT PRODUCTS, INC.

Calcium hydroxide dental cement
Primary Device ID00883205104038
NIH Device Record Key164fc01c-5aaf-41c5-8534-4d79b0f713c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra-Blend Plus
Version Model Number1016
Catalog Number1016
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 Kittrue
Device Combination Productfalse
Single Usefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205104038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJKLINER, CAVITY, CALCIUM HYDROXIDE

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 Date2016-09-22

On-Brand Devices [Ultra-Blend Plus]

00883205104038Ultra-Blend Plus Mini Kit Universal
00883205103611Ultra-Blend Plus Kit
00883205103604Ultra-Blend Plus Dentin Refill
00883205103598Ultra-Blend Plus Opaque White Refill

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