Implant Prosthetics 9001959

GUDID 00842092130049

3i Certain 6.0mm Non-Engaging Titanium Base

PREAT CORPORATION

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00842092130049
• NIH Device Record Key: 8ff4d8c0-b883-4bc1-96ac-291428d58ddd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant Prosthetics
• Version Model Number: 9001959
• Catalog Number: 9001959
• Company DUNS: 054875224
• Company Name: PREAT CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: lauren@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com
• Phone: +1(800) 232-7732
• Email: info@preat.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842092130049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183518

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM
• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00842092130049]

Moist Heat or Steam Sterilization

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-06
• Device Publish Date: 2022-06-28

On-Brand Devices [Implant Prosthetics]

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