O-Ring 1600824

GUDID 00842092131794

O-Ring Ball Abutment Neoss 3.5-6.0mm x 4mm

PREAT CORPORATION

Dental implant suprastructure, permanent, preformed
Primary Device ID00842092131794
NIH Device Record Key85195004-f1e0-490a-9643-34feb5729a99
Commercial Distribution StatusIn Commercial Distribution
Brand NameO-Ring
Version Model Number1600824
Catalog Number1600824
Company DUNS054875224
Company NamePREAT CORPORATION
Device Count1
DM Exemptfalse
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(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emaillauren@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com
Phone+1(800) 232-7732
Emailinfo@preat.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842092131794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842092131794]

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Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-06
Device Publish Date2022-06-28

On-Brand Devices [O-Ring]

00842092138038Biohorizons 3.5mm x 4.5mm Non-Engaging Titanium Base
00842092132425O-Ring Ball Abutment Straumann Tissue Level RN x 4mm
00842092132418O-Ring Ball Abutment Straumann Tissue Level RN x 3mm
00842092132401O-Ring Ball Abutment Straumann Tissue Level RN x 2mm
00842092132395O-Ring Ball Abutment Straumann Tissue Level RN x 1mm
00842092132388O-Ring Ball Abutment Straumann Tissue Level RN x 0mm
00842092132371O-Ring Ball Abutment Straumann Bone Level RC x 6mm
00842092132364O-Ring Ball Abutment Straumann Bone Level RC x 5mm
00842092132357O-Ring Ball Abutment Straumann Bone Level RC x 4mm
00842092132340O-Ring Ball Abutment Straumann Bone Level RC x 3mm
00842092132333O-Ring Ball Abutment Straumann Bone Level RC x 1mm
00842092132326O-Ring Ball Abutment Straumann Bone Level RC x 2mm
00842092132319O-Ring Ball Abutment Straumann Bone Level NC x 5mm
00842092132302O-Ring Ball Abutment Straumann Bone Level NC x 4mm
00842092132296O-Ring Ball Abutment Straumann Bone Level NC x 2mm
00842092132289O-Ring Ball Abutment Straumann Bone Level NC x 3mm
00842092132272O-Ring Ball Abutment Straumann Bone Level NC x 1mm
00842092132265O-Ring Ball Abutment Straumann Bone Level NC x 0mm
00842092132258O-Ring Ball Abutment Nobel Tri-Lobe WP x 5mm
00842092132241O-Ring Ball Abutment Nobel Tri-Lobe WP x 4mm
00842092132234O-Ring Ball Abutment Nobel Tri-Lobe WP x 2mm
00842092132227O-Ring Ball Abutment Nobel Tri-Lobe WP x 3mm
00842092132210O-Ring Ball Abutment Nobel Tri-Lobe WP x 1mm
00842092132203O-Ring Ball Abutment Nobel Tri-Lobe RP x 6mm
00842092132197O-Ring Ball Abutment Nobel Tri-Lobe RP x 5mm
00842092132180O-Ring Ball Abutment Nobel Tri-Lobe RP x 4mm
00842092132173O-Ring Ball Abutment Nobel Tri-Lobe RP x 3mm
00842092132166O-Ring Ball Abutment Nobel Tri-Lobe RP x 2mm
00842092132159O-Ring Ball Abutment Nobel Tri-Lobe RP x 1mm
00842092132142O-Ring Ball Abutment Nobel Tri-Lobe RP x 0mm
00842092132135O-Ring Ball Abutment Nobel Tri-Lobe NP x 5mm
00842092132128O-Ring Ball Abutment Nobel Tri-Lobe NP x 4mm
00842092132111O-Ring Ball Abutment Nobel Tri-Lobe NP x 3mm
00842092132104O-Ring Ball Abutment Nobel Tri-Lobe NP x 2mm
00842092132098O-Ring Ball Abutment Nobel Tri-Lobe NP x 1mm
00842092132081O-Ring Ball Abutment Nobel Tri-Lobe NP x 0mm
00842092132067O-Ring Ball Abutment Nobel Active/Conical RP x 5mm
00842092132050O-Ring Ball Abutment Nobel Active/Conical RP x 4mm
00842092131909O-Ring Ball Abutment Nobel Active/Conical RP x 3mm
00842092131893O-Ring Ball Abutment Nobel Active/Conical RP x 2mm
00842092131886O-Ring Ball Abutment Nobel Active/Conical RP x 1mm
00842092131879O-Ring Ball Abutment Nobel Active/Conical NP x 6mm
00842092131862O-Ring Ball Abutment Nobel Active/Conical NP x 5mm
00842092131855O-Ring Ball Abutment Nobel Active/Conical NP x 4mm
00842092131848O-Ring Ball Abutment Nobel Active/Conical NP x 3mm
00842092131824O-Ring Ball Abutment Nobel Active/Conical NP x 1mm
00842092131817O-Ring Ball Abutment Neoss 3.5-6.0mm x 6mm
00842092131800O-Ring Ball Abutment Neoss 3.5-6.0mm x 5mm
00842092131794O-Ring Ball Abutment Neoss 3.5-6.0mm x 4mm
00842092131787O-Ring Ball Abutment Neoss 3.5-6.0mm x 3mm
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