Tatum Surgical-ITO Small Ball Analog Analog ITO 3.0-5.0 (SB)

GUDID 00083208104619

Tatum One-Piece Analog for Small Ball Implants and abutments - size 3.0-5.0mm

Suncoast Dental, Inc

Dental implant analog Dental implant analog
Primary Device ID00083208104619
NIH Device Record Key34190edd-7f7f-4ed0-b193-972affb981a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTatum Surgical-ITO Small Ball Analog
Version Model NumberAnalog (SB) 3.0-5.0
Catalog NumberAnalog ITO 3.0-5.0 (SB)
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

Device Dimensions

Outer Diameter3 Millimeter
Outer Diameter3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100083208104619 [Primary]
GS100083208104619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous
NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by Suncoast Dental, Inc

00083208104619 - Tatum Surgical-ITO Small Ball Analog2020-05-19Tatum One-Piece Analog for Small Ball Implants and abutments - size 3.0-5.0mm
00083208104619 - Tatum Surgical-ITO Small Ball Analog2020-05-19 Tatum One-Piece Analog for Small Ball Implants and abutments - size 3.0-5.0mm
00083208100031 - Tatum Surgical/Unipost 2.5mm LH Healing Screw for D, S, & T Implants2020-05-18 Tatum Unipost Healing Screw for D, S, & T implants - Packed with Implant
00083208101328 - Tatum Surgical Unipost System2020-05-18 Unipost UCLA Retention screw 2.5mm LH to fit Unipost Implants D, S, & T
00083208103018 - Tatum Surgical-Analog2020-05-11 Dental Analog, ITO Unipost 3.5x14mm
00083208103117 - Tatum Surgical-Analog2020-05-11 Dental Analog, ITO Unipost 4.0x11mm
00083208103216 - Tatum Surgical-Analog2020-05-11 Dental Analog, ITO Unipost 4.0x14mm
00083208103315 - Tatum Surgical-Analog2020-05-11 Dental Analog, ITO Unipost 4.0x17mm
00083208103414 - Tatum Surgical-Analog2020-05-11 Dental Analog, ITO Unipost 4.5x14mm

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