GoDirect® Implant 433011L

GUDID 10841307122180

Ø3.0 x 11.5 Shoulder Height 3.0mm

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307122180
• NIH Device Record Key: 2abb78c9-21bc-49f7-90df-b78f748d84a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoDirect® Implant
• Version Model Number: 433011L
• Catalog Number: 433011L
• 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	10841307122180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090234

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: 2015-12-29

On-Brand Devices [GoDirect® Implant]

• 10841307121978: 3.0mmD x 8mmL, 1.5mm Height
• 10841307122241: 3.7mmD x 8mmL, 3.0mm Height
• 10841307122067: 3.7mmD x 8mmL, 1.5mm Height
• 10841307100041: 3.0mmD x 13mmL, 1.5mm Height
• 10841307122272: Ø3.7 x 13 Shoulder Height 3.0mm
• 10841307122265: Ø3.7 x 11.5 Shoulder Height 3.0mm
• 10841307122258: Ø3.7 x 10 Shoulder Height 3.0mm
• 10841307122197: Ø3.0 x 13 Shoulder Height 3.0mm
• 10841307122180: Ø3.0 x 11.5 Shoulder Height 3.0mm
• 10841307122173: Ø3.0 x 10 Shoulder Height 3.0mm
• 10841307122142: Ø4.7 x 13 Shoulder Height 1.5mm
• 10841307122128: Ø4.7 x 10 Shoulder Height 1.5mm
• 10841307122111: Ø4.7 x 8 Shoulder Height 1.5mm
• 10841307122098: Ø3.7 x 13 Shoulder Height 1.5mm
• 10841307122081: Ø3.7 x 11.5 Shoulder Height 1.5mm
• 10841307122074: Ø3.7 x 10 Shoulder Height 1.5mm
• 10841307122005: Ø3.0 x 13 Shoulder Height 1.5mm
• 10841307121992: Ø3.0 x 11.5 Shoulder Height 1.5mm
• 10841307121985: Ø3.0 x 10 Shoulder Height 1.5mm