Tall Separable Fastener 10PK, Omnibut

GUDID D990TSF10PKOA0

Smart Denture Conversions, LLC

Dental prosthesis/implant abutment screw analog, single-use

• Primary Device ID: D990TSF10PKOA0
• NIH Device Record Key: d9d1dd26-3429-499f-9d82-c47115e58d5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tall Separable Fastener 10PK, Omnibut
• Version Model Number: TSF10PK-OA
• Company DUNS: 010613514
• Company Name: Smart Denture Conversions, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com
• Phone: 8555500707
• Email: contact@smartdentureconversions.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D990TSF10PKOA0 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

[D990TSF10PKOA0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-11
• Device Publish Date: 2024-11-01

Devices Manufactured by Smart Denture Conversions, LLC

• D990CC10PK0 - Comfort Cap 10PK: 2025-02-28
• D990HC10PK0 - Healing Cap 10PK: 2025-02-28
• D990OS10PK0 - Orientation Screw 10PK: 2025-02-28
• D990CA10PK0 - Cementation Aid 10PK: 2024-11-11
• D990CTB10PK0 - Cementable TiBase 10PK: 2024-11-11
• D990GSB10PK0 - Gingival Scan Body 10PK: 2024-11-11
• D990HSG10PK0 - Horizontal Scan Gauge 10PK: 2024-11-11
• D990OTICMU5PK0 - Open Tray Impression Coping Multi-Unit 5PK: 2024-11-11