O-Ring 1705404

GUDID 00816577023768

O-Ring Ball Abutment BioHorizons 3.5mm x 4mm

PREAT CORPORATION

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00816577023768
• NIH Device Record Key: 385439fb-1ef0-4325-8110-d8f8910222e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Ring
• Version Model Number: 1705404
• Catalog Number: 1705404
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816577023768 [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

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

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[00816577023768]

Moist Heat or Steam Sterilization

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[00816577023768]

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[00816577023768]

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[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

[00816577023768]

Moist Heat or Steam Sterilization

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 [O-Ring]

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