Opalustre 554

GUDID 00883205103574

Opalustre Kit

ULTRADENT PRODUCTS, INC.

Dental abrasive powder
Primary Device ID00883205103574
NIH Device Record Key4ed3352a-b906-46ee-9eba-6d3ca55a070c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpalustre
Version Model Number554
Catalog Number554
Company DUNS013369913
Company NameULTRADENT PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205103574 [Primary]

FDA Product Code

EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-23

On-Brand Devices [Opalustre]

00883205103574Opalustre Kit
00883205103567Opalustre Refill

Trademark Results [Opalustre]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPALUSTRE
OPALUSTRE
75767451 2460976 Live/Registered
Ultradent Products, Inc.
1999-08-04
OPALUSTRE
OPALUSTRE
75443181 not registered Dead/Abandoned
ULTRADENT PRODUCTS, INC.
1998-03-02

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