Legacy™1 Implant 804210

GUDID 10841307100843

Ø4.2 x 10 Platform 3.5mmD

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307100843
• NIH Device Record Key: 87244873-5035-4f85-af05-d1f2b91971ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legacy™1 Implant
• Version Model Number: 804210
• Catalog Number: 804210
• 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	10841307100843 [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: 2024-12-17
• Device Publish Date: 2015-09-14

On-Brand Devices [Legacy™1 Implant]

• 10841307100966: Ø5.7 x 13 Platform 5.7mmD
• 10841307100959: Ø5.7 x 11.5 Platform 5.7mmD
• 10841307100942: Ø5.7 x 10 Platform 5.7mmD
• 10841307100935: Ø5.7 x 8 Platform 5.7mmD
• 10841307100928: Ø4.7 x 16 Platform 4.5mmD
• 10841307100911: Ø4.7 x 13 Platform 4.5mmD
• 10841307100904: Ø4.7 x 11.5 Platform 4.5mmD
• 10841307100898: Ø4.7 x 10 Platform 4.5mmD
• 10841307100881: Ø4.7 x 8 Platform 4.5mmD
• 10841307100874: Ø4.2 x 16 Platform 3.5mmD
• 10841307100867: Ø4.2 x 13 Platform 3.5mmD
• 10841307100850: Ø4.2 x 11.5 Platform 3.5mmD
• 10841307100843: Ø4.2 x 10 Platform 3.5mmD
• 10841307100836: Ø4.2 x 8 Platform 3.5mmD
• 10841307100829: Ø3.7 x 16 Platform 3.5mmD
• 10841307100812: Ø3.7 x 13 Platform 3.5mmD
• 10841307100805: Ø3.7 x 11.5 Platform 3.5mmD
• 10841307100799: Ø3.7 x 10 Platform 3.5mmD
• 10841307100782: Ø3.7 x 8 Platform 3.5mmD