Turbo-CR 1100-00

GUDID 00766054002994

Calculus Softener

ESSENTIAL DENTAL SYSTEMS, INC.

Dental scaling solution
Primary Device ID00766054002994
NIH Device Record Key53cebd6c-f2b3-469d-b021-359a0fb5dd3a
Commercial Distribution Discontinuation2025-04-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTurbo-CR
Version Model Number1100-00
Catalog Number1100-00
Company DUNS101147171
Company NameESSENTIAL DENTAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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(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
GS100766054002994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

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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