simply RePlant® Implant 604311U

GUDID 10841307108306

Ø4.3 x 11.5 Platform 4.3mmD

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307108306
• NIH Device Record Key: fbd4704b-cfa4-4b60-8c5d-b4d5002e2bb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simply RePlant® Implant
• Version Model Number: 604311U
• Catalog Number: 604311U
• 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: true
• 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

Device Dimensions

• 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	10841307108306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061319

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-12-19
• Device Publish Date: 2015-09-14

On-Brand Devices [simply RePlant® Implant]

• 10841307108405: Ø6.0 x 11.5 Platform 6.0mmD
• 10841307108399: Ø6.0 x 10 Platform 6.0mmD
• 10841307108382: Ø6.0 x 8 Platform 6.0mmD
• 10841307108375: Ø5.0 x 16 Platform 5.0mmD
• 10841307108368: Ø5.0 x 13 Platform 5.0mmD
• 10841307108351: Ø5.0 x 11.5 Platform 5.0mmD
• 10841307108344: Ø5.0 x 10 Platform 5.0mmD
• 10841307108337: Ø5.0 x 8 Platform 5.0mmD
• 10841307108320: Ø4.3 x 16 Platform 4.3mmD
• 10841307108313: Ø4.3 x 13 Platform 4.3mmD
• 10841307108306: Ø4.3 x 11.5 Platform 4.3mmD
• 10841307108290: Ø4.3 x 10 Platform 4.3mmD
• 10841307108283: Ø3.7 x 8 Platform 3.5mmD
• 10841307108276: Ø3.7 x 8 Platform 3.5mmD
• 10841307108269: Ø3.7 x 8 Platform 3.5mmD
• 10841307108252: Ø3.7 x 8 Platform 3.5mmD
• 10841307108245: Ø3.7 x 8 Platform 3.5mmD
• 10841307108238: Ø3.7 x 8 Platform 3.5mmD