Legacy™ Healing Collar Anodized 8530-13A

GUDID 10841307111443

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307111443
• NIH Device Record Key: 56b4add0-c7f4-4029-8e0d-e3e850fe34f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legacy™ Healing Collar Anodized
• Version Model Number: 8530-13A
• Catalog Number: 8530-13A
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307111443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090234

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-14

On-Brand Devices [Legacy™ Healing Collar Anodized]

• 10841307111450: 8530-15A
• 10841307111443: 8530-13A
• 10841307111412: 8057-15A
• 10841307111405: 8057-13A
• 10841307111399: 8045-15A
• 10841307111382: 8045-13A
• 10841307111375: 8035-15A
• 10841307111368: 8035-13A