DIRECTarch™ Fiducial Marker 8mm - 4 Pack DA-Marker8-4

GUDID 00841307135855

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00841307135855
• NIH Device Record Key: d7a35a20-7a32-4ee3-a217-3f1b9bc90f8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTarch™ Fiducial Marker 8mm - 4 Pack
• Version Model Number: DA-Marker8-4
• Catalog Number: DA-Marker8-4
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Device Count: 4
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841307135855 [Unit of Use]
GS1	10841307135852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230143

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: 2
• Public Version Date: 2025-12-04
• Device Publish Date: 2025-10-31

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

• 10841307135340 - Legacy™ DIRECTarch™ 3.0 MUA Replacement Screw: 2025-12-10
• 10841307135357 - Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL Collar: 2025-12-10
• 10841307135364 - Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL Collar: 2025-12-10
• 10841307135371 - Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL Collar: 2025-12-10
• 10841307135388 - Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL Collar: 2025-12-10
• 10841307135395 - Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL Collar: 2025-12-10
• 10841307135401 - Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL Collar: 2025-12-10
• 10841307135418 - Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL Collar: 2025-12-10