ScrewIndirect® Implant Gold/Plastic Coping 4000-67

GUDID 10841307114260

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307114260
• NIH Device Record Key: b34f2b21-9473-44b7-977a-c90eb4ab1206
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScrewIndirect® Implant Gold/Plastic Coping
• Version Model Number: 4000-67
• Catalog Number: 4000-67
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307114260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061319

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307114260]

Moist Heat or Steam Sterilization

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

• 10841307111627 - Legacy™ Plastic Engaging Temporary Abutment: 2024-12-23
• 10841307111634 - Legacy™ Plastic Engaging Temporary Abutment: 2024-12-23
• 10841307111641 - Legacy™ Plastic Engaging Temporary Abutment: 2024-12-23
• 10841307111696 - Legacy™ Plastic Temporary Abutment: 2024-12-23
• 10841307103585 - ReActive® Implant: 2024-12-20 Ø3.7 x 8 Platform 3.5mmD
• 10841307103592 - ReActive® Implant: 2024-12-20 Ø3.7 x 8 Platform 3.5mmD
• 10841307103608 - ReActive® Implant: 2024-12-20 Ø3.7 x 8 Platform 3.5mmD
• 10841307103615 - ReActive® Implant: 2024-12-20 Ø3.7 x 8 Platform 3.5mmD