SimplyIconic™InterActive™ Fixation Screw, NE 1000-52B

GUDID 10841307129295

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307129295
• NIH Device Record Key: e1c0ccb0-faf9-4b7b-ac8f-b15fc4b7c684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimplyIconic™InterActive™ Fixation Screw, NE
• Version Model Number: 1000-52B
• Catalog Number: 1000-52B
• 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
• 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
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307129295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223535

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

[10841307129295]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [SimplyIconic™InterActive™ Fixation Screw, NE]

• 10841307129295: 1000-52B
• 10841307129288: 1000-54B