Tatum Surgical IP Press Fit Abutment IP-PN-4.5 x 5 (CB)

GUDID 00083208455216

0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece
Primary Device ID00083208455216
NIH Device Record Key154afed8-f273-4e3e-821c-98dd84dad774
Commercial Distribution StatusIn Commercial Distribution
Brand NameTatum Surgical IP Press Fit Abutment
Version Model NumberIP-PN-4.5 x 5 (CB) Abutment
Catalog NumberIP-PN-4.5 x 5 (CB)
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

Phone727-536-4880
Emailtatumcompliance@gmail.com

Device Dimensions

Outer Diameter4.5 Millimeter
Height5 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100083208455216 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00083208455216]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-01-13
Device Publish Date2021-06-04

On-Brand Devices [Tatum Surgical IP Press Fit Abutment]

000832085062150° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 6.0mm Cuff Height
000832085052180° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 5.0mm Cuff Height
000832085042110° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 4.0mm Cuff Height
000832085032140° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 3.0mm Cuff Height
000832085022170° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 2.0mm Cuff Height
000832084562130° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 6.0mm Cuff Height
000832084552160° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height
000832084542190° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 4.0mm Cuff Height
000832084532120° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height
000832084522150° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 2.0mm Cuff Height

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.