Replace® Select 28954

GUDID 07332747022568

Replace Select Straight TiU RP 4.3x15mm

Nobel Biocare AB

Screw endosteal dental implant, two-piece

• Primary Device ID: 07332747022568
• NIH Device Record Key: f875c8c3-eca0-4b28-9451-0a4a0d003f19
• Commercial Distribution Discontinuation: 2019-03-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Replace® Select
• Version Model Number: 28954
• Catalog Number: 28954
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• 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(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747022568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023113

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: 5
• Public Version Date: 2019-10-21
• Device Publish Date: 2015-09-17

On-Brand Devices [Replace® Select]

• 07332747022612: Replace Select Straight TiU WP 5.0x15mm
• 07332747022605: Replace Select Straight TiU WP 5.0x13mm
• 07332747022599: Replace Select Straight TiU WP 5.0x11.5
• 07332747022582: Replace Select Straight TiU WP 5.0x10mm
• 07332747022575: Replace Select Straight TiU RP 4.3x18mm
• 07332747022568: Replace Select Straight TiU RP 4.3x15mm
• 07332747022551: Replace Select Straight TiU RP 4.3x13mm
• 07332747022544: Replace Select Straight TiU RP 4.3x11.5
• 07332747022537: Replace Select Straight TiU RP 4.3x10mm
• 07332747022520: Replace Select Straight TiU NP 3.5x15mm
• 07332747022513: Replace Select Straight TiU NP 3.5x13mm
• 07332747022506: Replace Select Straight TiU NP 3.5x11.5
• 07332747022490: Replace Select Straight TiU NP 3.5x10mm