Essix ACE® 1AH20-50

GUDID D7461AH20501

Essix ACE® Plastic - .035in 120mm Circle

RAINTREE ESSIX INC.

Dental implant template, radiographic
Primary Device IDD7461AH20501
NIH Device Record Key452d8236-2ffa-4e02-a6d3-500cdbb31813
Commercial Distribution StatusIn Commercial Distribution
Brand NameEssix ACE®
Version Model Number1AH20-50
Catalog Number1AH20-50
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
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
HIBCCD7461AH20500 [Unit of Use]
HIBCCD7461AH20501 [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 [Essix ACE®]

D7461AH50PLAS1Essix ACE® Plastic - .035in Vac 5" Square
D7461AH50501Essix ACE Plastic .035 x 125mm Square 50pk
D7461AH501Essix ACE Plastic .035 x Vacuum Square 100pk
D7461AH347501Essix ACE® Plastic - .035in 125mm Square
D7461AH3471Essix ACE Plastic - .035in 125mm Square 100pk
D7461AH25SH1Essix ACE® Plastic - .035in 125mm Circle Shinwon
D7461AH25501Essix ACE® Plastic - .035in 125mm Circle
D7461AH251Essix ACE Plastic 035 x 125mm Circle 100pk
D7461AH20501Essix ACE® Plastic - .035in 120mm Circle
D7461A478501Essix ACE® Plastic - .040in 125mm Square

Trademark Results [Essix ACE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESSIX ACE
ESSIX ACE
78353800 3093929 Live/Registered
DENTSPLY SIRONA ORTHODONTICS INC.
2004-01-19

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