Fixation Screw Large Diameter 1000-52

GUDID 00841307126235

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00841307126235
• NIH Device Record Key: 780a104f-70ab-4e11-b19b-ac075a4cad74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation Screw Large Diameter
• Version Model Number: 1000-52
• Catalog Number: 1000-52
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Device Count: 2
• 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: 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: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841307126235 [Unit of Use]
GS1	10841307126232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130572

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

[00841307126235]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [Fixation Screw Large Diameter]

• 00841307126235: 1000-52
• 00841307132434: 1000-52