Implant Prosthetics 9006432-10

GUDID 00842092136133

GCL Astra Ev 3.0 Engaging Verification Cylinder (10-Pack)

PREAT CORPORATION

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID00842092136133
NIH Device Record Key5ecf9070-c305-4cae-b4c7-bbb0cba2912a
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant Prosthetics
Version Model Number9006432-10
Catalog Number9006432-10
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 Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842092136133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

[00842092136133]

Moist Heat or Steam Sterilization

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 [Implant Prosthetics]

00842092124314MegaGen Anyridge Multi Unit Titanium Screw
00842092124307Hiossen HG Standard Multi Unit Titanium Screw
00842092124291Hiossen HG Mini Multi Unit Titanium Screw
00842092123485Multi-Unit Titanium Screw (.050 Hex) (10-Pack)
00842092123478Multi-Unit Titanium Screw (.050 Hex)
00842092123409Multi-Unit Titanium Screw (.048 Hex) (10-Pack)
00842092123393Multi-Unit Titanium Screw (.048 Hex)
00842092123386Multi-Unit Titanium Screw (SCS) (10-Pack)
00842092123379Multi-Unit Titanium Screw (SCS)
00842092123294Straumann Tissue Level RN Prepable Titanium Abutment
00842092123171MegaGen AnyRidge Titanium Screw (10-pack)
00842092123102Hiossen HG Mini Titanium Screw (10-Pack)
00842092123096Multi-Unit Plastic Coping .050 Screw
00842092123072MegaGen AnyRidge 30° Multi-Unit Abutment x 6.5mm
00842092123065MegaGen AnyRidge 30° Multi-Unit Abutment x 5.5mm
00842092123058MegaGen AnyRidge 30° Multi-Unit Abutment x 4.5mm
00842092123041MegaGen AnyRidge 30° Multi-Unit Abutment x 3.5mm
00842092123034MegaGen AnyRidge 17° Multi-Unit Abutment x 5.5mm
00842092123027MegaGen AnyRidge 17° Multi-Unit Abutment x 4.5mm
00842092123010MegaGen AnyRidge 17° Multi-Unit Abutment x 3.5mm
00842092123003MegaGen AnyRidge Straight Multi-Unit Abutment x 5mm
00842092122990MegaGen AnyRidge Straight Multi-Unit Abutment x 4mm
00842092122983MegaGen AnyRidge Straight Multi-Unit Abutment x 3mm
00842092122860MegaGen AnyRidge Straight Multi-Unit Abutment x 2mm
00842092122839MegaGen AnyRidge Esthetic Abutment Straight, Posterior
00842092122822MegaGen AnyRidge Esthetic Abutment 15° Angle, Posterior
00842092122815MegaGen AnyRidge Esthetic Abutment Straight, Anterior
00842092122808MegaGen AnyRidge Esthetic Abutment 15° Angle, Anterior
00842092122792MegaGen AnyRidge x 6.0mm Titanium Base
00842092122785MegaGen AnyRidge x 4.5mm Titanium Base
00842092122778MegaGen AnyRidge 5.0mm x 4.5mm Non-Engaging Titanium Base
00842092122761MegaGen AnyRidge 3.5mm x 4.5mm Non-Engaging Titanium Base
00842092122754MegaGen AnyRidge Titanium Screw
00842092122730Straumann Tissue Level WN x 6mm Titanium Base
00842092122723Straumann Tissue Level WN x 4.5mm Titanium Base
00842092122716Straumann Tissue Level WN x 4.5mm Non-Engaging Titanium Base
00842092122709Straumann Tissue Level RN x 6mm Titanium Base
00842092122693Straumann Tissue Level RN x 4.5mm Titanium Base
00842092122686Straumann Tissue Level RN x 4.5mm Non-Engaging Titanium Base
00842092122679Hiossen HG Standard Esthetic Abutment Straight, Posterior
00842092122662Hiossen HG Standard Esthetic Abutment 15° Angle, Posterior
00842092122655Hiossen HG Standard Esthetic Abutment 15° Angle, Anterior
00842092122648Hiossen HG Mini Esthetic Abutment Straight, Posterior
00842092122631Hiossen HG Mini Esthetic Abutment 15° Angle, Posterior
00842092122624Hiossen HG Mini Esthetic Abutment Straight, Anterior
00842092122617Hiossen HG Mini Esthetic Abutment 15° Angle, Anterior
00842092122600Hiossen HG Mini x 6mm Titanium Base
00842092122594Hiossen HG Mini x 4.5mm Titanium Base
00842092122587Nobel Active/Conical WP Esthetic Abutment Straight, Posterior
00842092122570Nobel Active/Conical WP x 4.5mm Non-Engaging Titanium Base
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