DIRECTarch™ Open Tray Impression Transfer (QTY 1) DA1000-62

GUDID 10841307135319

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 10841307135319
• NIH Device Record Key: eb99cf53-1010-43c7-91ff-f0354e0ab11a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTarch™ Open Tray Impression Transfer (QTY 1)
• Version Model Number: DA1000-62
• Catalog Number: DA1000-62
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING 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: true
• 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	10841307135319 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

[10841307135319]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-26
• Device Publish Date: 2025-09-18

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

• 10841307135302 - DIRECTarch™ Closed Tray Impression Transfer (QTY 1): 2025-09-26
• 10841307135319 - DIRECTarch™ Open Tray Impression Transfer (QTY 1): 2025-09-26
• 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