Bone Expander Screw Kit Bone Expander Screw Kit

GUDID 00083208005558

Bone Expander Screw Kit (5). Contains 2.6, 3.0, 3.4, 3.8 and 4.3mm Expanders, Ratchet Wrench, Ratchet Extender, Latch Grip Adapter, Thumb Wrench, and Box Used to create an osteotomy for Implant placement.

Suncoast Dental, Inc

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system
Primary Device ID00083208005558
NIH Device Record Keyc580c722-31a7-4962-b000-2565063cbee4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Expander Screw Kit
Version Model NumberBone Expander Screw Kit
Catalog NumberBone Expander Screw Kit
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100083208005558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


[00083208005558]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

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00083208453212 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height
00083208454219 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 4.0mm Cuff Height
00083208455216 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height
00083208456213 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 6.0mm Cuff Height
00083208502217 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 2.0mm Cuff Height

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