Nobel Active 8004730

GUDID 00842092163054

Nobel Active/Conical 3.0mm Engaging Verification Cylinder Kit contains: 1 Nobel Active/Conical 3.0mm Engaging Verification Cylinder (00842092114377) 1 Nobel Active/Conical 3.0mm Guide Pin 20mm (00842092114407) 1 Nobel Active/Conical 3.0mm Titanium Screw (00842092117583)

PREAT CORPORATION

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00842092163054
NIH Device Record Key1d0b26b5-54c1-4f0e-95c6-412126e0ac29
Commercial Distribution StatusIn Commercial Distribution
Brand NameNobel Active
Version Model Number8004730
Catalog Number8004730
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842092163054 [Package]
Contains: 00842092168189
Package: [10 Units]
In Commercial Distribution
GS100842092163061 [Package]
Contains: 00842092168189
Package: [25 Units]
In Commercial Distribution
GS100842092168189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[00842092163054]

Moist Heat or Steam Sterilization


[00842092163054]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-16
Device Publish Date2022-09-08

On-Brand Devices [Nobel Active]

00842092163054Nobel Active/Conical 3.0mm Engaging Verification Cylinder Kit contains: 1 Nobel Active/Conical 3
00842092180044Nobel Active/Conical WP Non-Engaging Verification Cylinder
00842092180020Nobel Active/Conical WP Engaging Verification Cylinder

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