LC Block-Out 241

GUDID 00883205103352

LC Block-Out Resin Refill

ULTRADENT PRODUCTS, INC.

Dental articulation paste/solution
Primary Device ID00883205103352
NIH Device Record Keyf832d44b-4aa9-4e0c-9539-8d74a94a42c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLC Block-Out
Version Model Number241
Catalog Number241
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 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
GS100883205103352 [Primary]

FDA Product Code

EBHMATERIAL, IMPRESSION TRAY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-23
Device Publish Date2017-09-20

On-Brand Devices [LC Block-Out]

00883205103369LC Block-Out Resin Kit
00883205103352LC Block-Out Resin Refill
00883205103345LC Block-Out Resin Econo Refill

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