Ideal Clear IS25-110-60

GUDID D746IS25110601

Ideal Clear 060 125MM Circle Biostar

RAINTREE ESSIX INC.

Dental implant template, radiographic
Primary Device IDD746IS25110601
NIH Device Record Key96665a7f-a6bb-4e43-9c3a-8c1be3c041ca
Commercial Distribution Discontinuation2018-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIdeal Clear
Version Model NumberIS25-110-60
Catalog NumberIS25-110-60
Company DUNS801157132
Company NameRAINTREE ESSIX INC.
Device Count50
DM Exempttrue
Pre-market Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD746IS25110600 [Unit of Use]
HIBCCD746IS25110601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQCMouthguard, prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-22
Device Publish Date2016-09-24

On-Brand Devices [Ideal Clear]

D746IS25110801Ideal Clear 080 125MM Circle Biostar
D746IS25110411Ideal Clear 040 120MM Circle Erko
D746IS25110401Ideal Clear 040 125MM Circle Biostar
D746IS25110201Ideal Clear 020 125MM Circle Biostar
D746IS25110601Ideal Clear 060 125MM Circle Biostar
D746IS25110311Ideal Clear 030 120MM Circle Erko
D746IS25110301Ideal Clear 030 125MM Circle Biostar
D746IS25100851Ideal Clear 080 127MM Square
D746IS25100651Ideal Clear 060 127MM Square
D746IS25100451Ideal Clear 040 127MM Square
D746IS25100301Ideal Clear 030 125MM Square
D746IS25100251Ideal Clear 020 127MM Square

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