O - Ring Large Red O Ring Large Red

GUDID 00083208351310

Large O ring (Red) for Large ball post Housings that fit Large ball post for two piece implants

Suncoast Dental, Inc

Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment

• Primary Device ID: 00083208351310
• NIH Device Record Key: a219a51e-9f05-4c09-ad2d-feca95e14e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O - Ring Large Red
• Version Model Number: O Ring Large Red
• Catalog Number: O Ring Large Red
• Company DUNS: 078352849
• Company Name: Suncoast Dental, Inc
• Device Count: 1
• DM Exempt: true
• 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: false
• 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(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208351310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

[00083208351310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-21
• Device Publish Date: 2020-06-01

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• 00083208453212 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height
• 00083208454219 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 4.0mm Cuff Height
• 00083208455216 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height
• 00083208456213 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 6.0mm Cuff Height
• 00083208502217 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 2.0mm Cuff Height