Tatum Surgical-Analog Analog ITI OT 5.0 Xfer

GUDID 00083208100819

Dental Analog, Integrity Open Tray Transfer 5.0mm

Suncoast Dental, Inc

Dental implant analog
Primary Device ID00083208100819
NIH Device Record Keyde554e6c-9c9c-4c0c-a724-89561c6439f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTatum Surgical-Analog
Version Model NumberAnalog ITI OT 5.0 Xfer
Catalog NumberAnalog ITI OT 5.0 Xfer
Company DUNS078352849
Company NameSuncoast Dental, Inc
Device Count1
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100083208100819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

[00083208100819]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27

On-Brand Devices [Tatum Surgical-Analog]

00083208104411Dental Analog, Burn Out Small, fits small ball post
00083208104312Dental Analog, Burn Out Large, fits large ball post
00083208104213Dental Analog, Shim 4.0mm
00083208104114Dental Analog, ITO Unipost Crown and Bridge 6.0mm
00083208104015Dental Analog, ITO Unipost Crown and Bridge 5.0mm
00083208103919Dental Analog, ITO Unipost Crown and Bridge 4.0-4.5mm
00083208103810Dental Analog, ITO Unipost Crown and Bridge 3.5mm
00083208103711Dental Analog, ITO Unipost Crown and Bridge 3.0mm
00083208103612Dental Analog, ITO Unipost 5.0x17mm
00083208103513Dental Analog, ITO Unipost 5.0x14mm
00083208103414Dental Analog, ITO Unipost 4.5x14mm
00083208103315Dental Analog, ITO Unipost 4.0x17mm
00083208103216Dental Analog, ITO Unipost 4.0x14mm
00083208103117Dental Analog, ITO Unipost 4.0x11mm
00083208103018Dental Analog, ITO Unipost 3.5x14mm
00083208102912Dental Analog, Unipost 8.0mm
00083208102813Dental Analog, Unipost 7.0mm
00083208102714Dental Analog, Unipost 6.0mm
00083208102615Dental Analog, Unipost 5.0mm
00083208102516Dental Analog, Unipost 4.5mm
00083208102417Dental Analog, Unipost 4.0mm
00083208102318Dental Analog, Unipost 3.5mm
00083208102219Dental Analog, Integrity 8.0mm
00083208102110Dental Analog, Integrity 7.0mm
00083208102011Dental Analog, Integrity 6.0mm
00083208101915Dental Analog, Integrity 5.0mm
00083208101816Dental Analog, Integrity 4.5mm
00083208101717Dental Analog, Integrity 4.0mm
00083208101618Dental Analog, Integrity 3.7mm
00083208101519Dental Analog, Unipost 4.0mm Temporary Abutment
00083208101410Dental Analog, Unipost 4.0mm Transfer
00083208101311Dental Analog, Unipost UCLA 4.0mm
00083208101212Dental Analog, Integrity UCLA 6.0-8.0mm
00083208101113Dental Analog, Integrity UCLA 5.0mm
00083208101014Dental Analog, Integrity UCLA 3.7-4.5mm
00083208100918Dental Analog, Integrity Open Tray Transfer 6.0-8.0mm
00083208100819Dental Analog, Integrity Open Tray Transfer 5.0mm
00083208100710Dental Analog, Integrity Open Tray Transfer 3.7-4.5mm
00083208100611Dental Analog, Integrity 6.0-8.0mm
00083208100512Dental Analog, Integrity 5.0mm
00083208100413Dental Analog, Integrity 3.7-4.5mm
00083208100314Dental Analog, Temporary Abutment 6.0-8.0mm
00083208100215Dental Analog, Temporary Abutment 5.0mm
00083208100116Dental Analog, Temporary Abutment 3.7-4.5mm
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