Swish™ Healing Collar 9048-15H

GUDID 10841307127161

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307127161
• NIH Device Record Key: 2e173c6a-1b1d-4900-9ca5-93d0d9a3b91f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swish™ Healing Collar
• Version Model Number: 9048-15H
• Catalog Number: 9048-15H
• 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
• 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
• 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
• 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 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307127161 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

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