Turbo-CR 1100-100

GUDID 00766054003007

Disposable Fluoride Trays

ESSENTIAL DENTAL SYSTEMS, INC.

Fluoride gel tray
Primary Device ID00766054003007
NIH Device Record Key892064b0-3cad-479a-9747-f0a82772bd77
Commercial Distribution Discontinuation2025-04-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTurbo-CR
Version Model Number1100-100
Catalog Number1100-100
Company DUNS101147171
Company NameESSENTIAL DENTAL SYSTEMS, 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(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100766054003007 [Primary]

FDA Product Code

KMTTRAY, FLUORIDE, DISPOSABLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-14
Device Publish Date2025-04-04

On-Brand Devices [Turbo-CR]

00766054003007Disposable Fluoride Trays
00766054002994Calculus Softener
00766054002987Mixing Tips

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