InterActive® Implant 655010

GUDID 10841307100515

Ø5.0 x 10 Platform 3.4mmD (RP) Conical

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307100515
• NIH Device Record Key: f6e6e16a-ea5d-4544-b300-178ce1e1ee02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterActive® Implant
• Version Model Number: 655010
• Catalog Number: 655010
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10841307100515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130572

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: 2024-12-17
• Device Publish Date: 2015-09-14

On-Brand Devices [InterActive® Implant]

• 10841307100546: Ø5.0 x 16 Platform 3.4mmD (RP) Conical
• 10841307100539: Ø5.0 x 13 Platform 3.4mmD (RP) Conical
• 10841307100522: Ø5.0 x 11.5 Platform 3.4mmD (RP) Conical
• 10841307100515: Ø5.0 x 10 Platform 3.4mmD (RP) Conical
• 10841307100508: Ø5.0 x 8 Platform 3.4mmD (RP) Conical
• 10841307100492: Ø5.0 x 6 Platform 3.4mmD (RP) Conical
• 10841307100485: Ø4.3 x 16 Platform 3.4mmD (RP) Conical
• 10841307100478: Ø4.3 x 13 Platform 3.4mmD (RP) Conical
• 10841307100461: Ø4.3 x 11.5 Platform 3.4mmD (RP) Conical
• 10841307100454: Ø4.3 x 10 Platform 3.4mmD (RP) Conical
• 10841307100447: Ø4.3 x 8 Platform 3.4mmD (RP) Conical
• 10841307100430: Ø4.3 x 6 Platform 3.4mmD (RP) Conical
• 10841307100423: Ø3.7 x 16 Platform 3.0mmD (NP) Conical
• 10841307100416: Ø3.7 x 13 Platform 3.0mmD (NP) Conical
• 10841307100409: Ø3.7 x 11.5 Platform 3.0mmD (NP) Conical
• 10841307100393: Ø3.7 x 10 Platform 3.0mmD (NP) Conical
• 10841307100386: Ø3.7 x 8 Platform 3.0mmD (NP) Conical
• 10841307100379: Ø3.7 x 6 Platform 3.0mmD (NP) Conical
• 10841307100362: Ø3.2 x 16 Platform 3.0mmD (NP) Conical
• 10841307100355: Ø3.2 x 13 Platform 3.0mmD (NP) Conical
• 10841307100348: Ø3.2 x 11.5 Platform 3.0mmD (NP) Conical
• 10841307100331: Ø3.2 x 10 Platform 3.0mmD (NP) Conical
• 10841307100324: Ø3.2 x 8 Platform 3.0mmD (NP) Conical