Essix ACE 1A320-50

GUDID D7461A320501

Essix ACE .030 x 120mm PCTG Circle 50pk

RAINTREE ESSIX INC.

Dental implant template, radiographic
Primary Device IDD7461A320501
NIH Device Record Keyd68a96aa-fa2a-423a-a2c8-0327eda3145c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEssix ACE
Version Model Number1A320-50
Catalog Number1A320-50
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(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
HIBCCD7461A320500 [Unit of Use]
HIBCCD7461A320501 [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]

D74625325301ESSIX ACE (BX/100) RM008 (SAME AS RAINTREE PART 1A420)
D7461A4781Essix ACE 040 x 4.875" PCTG Vacuum Square 100pk
D7461A450SH1Essix ACE 040 x 5" PCTG Vacuum Square 20PK
D7461A450501Essix ACE .040 x 5" PCTG Square 50pk
D7461A4501Essix ACE 040 x 5" x 5" PCTG Vacuum Square 100pk
D7461A425SH1Essix ACE 040 x 125mm PCTG Vacuum Circle 20pk
D7461A425501Essix ACE .040 x 125mm PCTG Circle 50pk
D7461A4251Essix ACE 040 x 125mm PCTG Vacuum Circle 100pk
D7461A420501Essix ACE .040 x 120mm PCTG Circle 50pk
D7461A4201Essix ACE 040 x 120mm PCTG Vacuum Circle 100pk
D7461A350SH1Essix ACE 030 x 5" PCTG Vacuum Square 20PK
D7461A350501Essix ACE .030 x 5" PCTG Square 50pk
D7461A3501Essix ACE 030 x 5" PCTG Vacuum Square 100pk
D7461A347501Essix ACE .030 x 125mm Square 50pk
D7461A3471Essix ACE 030 x 125mm Square 100/PK
D7461A325SH1Essix ACE 030 x 125mm PCTG Vacuum Circle 20PK
D7461A325501Essix ACE .030 x 125mm PCTG Circle 50pk
D7461A3251Essix ACE 030 x 125mm PCTG Vacuum Circle 100pk
D7461A320501Essix ACE .030 x 120mm PCTG Circle 50pk
D7461A3201Essix ACE 030 x 120mm PCTG Vacuum Circle 100pk

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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