InterActive® Zirconia Abutment Base Wide 6534-30CWB

GUDID 10841307110453

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307110453
• NIH Device Record Key: 1898c471-33dc-4a23-8e58-659aaaf5406f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterActive® Zirconia Abutment Base Wide
• Version Model Number: 6534-30CWB
• Catalog Number: 6534-30CWB
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307110453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143011

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307110453]

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

• 10841307132110 - SimplyIconic™ / InterActive™ SMARTbase, Extra Narrow, Non-Engaging: 2025-02-10
• 10841307132127 - DIRECTguide™ Sleeve Narrow: 2025-02-10
• 00841307128598 - DIRECTguide™ Sleeve Narrow (5PK): 2025-02-10
• 10841307132141 - DIRECTguide™ Sleeve Regular: 2025-02-10
• 00841307128628 - DIRECTguide™ Sleeve Regular (5PK): 2025-02-10
• 10841307132165 - InterActive™ Fixture-Mount Analog Narrow: 2025-02-10
• 10841307132172 - Legacy™ Implant Open-Tray Transfer Concave Profile Non-Engaging Narrow: 2025-02-10
• 10841307132189 - Legacy™ SMARTbase, Non-Engaging: 2025-02-10