Swish™ Healing Collar 9048-13

GUDID 10841307116158

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307116158
• NIH Device Record Key: daf4c8be-6036-4ac6-9227-61dee40c83e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swish™ Healing Collar
• Version Model Number: 9048-13
• Catalog Number: 9048-13
• 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	10841307116158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081396

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 [Swish™ Healing Collar]

• 10841307116219: 9065-15
• 10841307116202: 9065-14
• 10841307116196: 9065-13
• 10841307116189: 9065-12
• 10841307116172: 9048-15
• 10841307116165: 9048-14
• 10841307116158: 9048-13
• 10841307116141: 9048-12
• 10841307116134: 9037-15
• 10841307116127: 9037-14
• 10841307116110: 9037-13
• 10841307116103: 9037-12
• 10841307127208: 9065-15H
• 10841307127192: 9065-14H
• 10841307127185: 9065-13H
• 10841307127178: 9065-12H
• 10841307127161: 9048-15H
• 10841307127154: 9048-14H
• 10841307127147: 9048-13H
• 10841307127130: 9048-12H
• 10841307127123: 9037-15H
• 10841307127116: 9037-14H
• 10841307127109: 9037-13H
• 10841307127093: 9037-12H