Sable Seek 1021

GUDID 00883205104007

Sable Seek Mini Kit Universal

ULTRADENT PRODUCTS, INC.

Dental caries detector, optical induced fluorescence
Primary Device ID00883205104007
NIH Device Record Keyb72ceaaa-b6d1-4c97-a3be-e6cd91373fd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSable Seek
Version Model Number1021
Catalog Number1021
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 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205104007 [Primary]

FDA Product Code

LFCDEVICE, CARIES DETECTION

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 Date2016-09-22

On-Brand Devices [Sable Seek]

00883205104007Sable Seek Mini Kit Universal
00883205103390Sable Seek Kit
00883205103383Sable Seek Refill
00883205103123Sable Seek Econo Refill

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