OpalCups 5172

GUDID 00883205032638

OpalCups Variety Pack

ULTRADENT PRODUCTS, INC.

Dental polishing cup, reusable
Primary Device ID00883205032638
NIH Device Record Key34affb91-59aa-423c-854b-d8823b9139df
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpalCups
Version Model Number5172
Catalog Number5172
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205032638 [Primary]

FDA Product Code

EHKCUP, PROPHYLAXIS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-19
Device Publish Date2025-03-11

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