Essix + 1APL40S125

GUDID D7461APL40S1251

Essix + Plastic 80 ct .040 (1mm) -125mm Square

RAINTREE ESSIX INC.

Dental implant template, radiographic
Primary Device IDD7461APL40S1251
NIH Device Record Key784b0eed-fbc5-4d27-b580-d1f0ab4a9c16
Commercial Distribution StatusIn Commercial Distribution
Brand NameEssix +
Version Model Number1APL40S125
Catalog Number1APL40S125
Company DUNS801157132
Company NameRAINTREE ESSIX INC.
Device Count80
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
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(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7461APL40S1250 [Unit of Use]
HIBCCD7461APL40S1251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, sequential

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 +]

D7461APL40S51Essix + Plastic 80 ct .040 (1mm) -5" Square
D7461APL40S1251Essix + Plastic 80 ct .040 (1mm) -125mm Square
D7461APL40C1251Essix + Plastic 80 ct .040 (1 mm) -125mm circle
D7461APL40C1201Essix + Plastic 80 ct .040 1 mm) -120mm circle
D7461APL35S51Essix + Plastic 80 ct .035 (7/8mm) -5" square
D7461APL35S1251Essix + Plastic 80 ct .035 (7/8mm) -125mm square
D7461APL35C1251Essix + Plastic 80 ct .035 (7/8mm) -125mm circle
D7461APL35C1201Essix + Plastic 80 ct .035 (7/8mm) -120mm circle

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