GoDirect® Implant Cover Screw 4500-01

GUDID 10841307109204

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307109204
• NIH Device Record Key: 86a63c7b-3ed0-4c1b-ae00-0ed4df5f444d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoDirect® Implant Cover Screw
• Version Model Number: 4500-01
• Catalog Number: 4500-01
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• 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: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307109204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090234

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-14

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

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• 10841307135319 - DIRECTarch™ Open Tray Impression Transfer (QTY 1): 2025-09-26
• 10841307135869 - Simply Surgical Kit Legacy: 2025-09-09 Drills & Tools (Qty 22) Tray (Qty 1)
• 10841307135876 - Simply Surgical Kit Conical: 2025-09-09 Drills & Tools (Qty 19) Tray (Qty 1)
• 10841307134855 - DIRECTarch™ Cylinder – 6.0mm: 2025-05-01
• 10841307135197 - DIRECTscan™ Adapter Kit - Empty: 2025-05-01
• 00841307135213 - DIRECTarch™ Direct to MUA Screw (10Pk): 2025-05-01
• 10841307132110 - SimplyIconic™ / InterActive™ SMARTbase, Extra Narrow, Non-Engaging: 2025-02-10