NobelReplace® 36900

GUDID 07332747034059

NobelReplace PS RP 5.0x16mm

Nobel Biocare AB

Screw endosteal dental implant, two-piece

• Primary Device ID: 07332747034059
• NIH Device Record Key: d047012f-b57a-4003-96fc-5fe350ada926
• Commercial Distribution Discontinuation: 2019-03-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NobelReplace®
• Version Model Number: 36900
• Catalog Number: 36900
• 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	07332747034059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050258

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 [NobelReplace®]

• 07332747073645: NobelReplace® Conical Connection PMC NP 3.5x8mm
• 07332747073638: NobelReplace® Conical Connection PMC NP 3.5x10mm
• 07332747073621: NobelReplace® Conical Connection PMC NP 3.5x11.5mm
• 07332747073614: NobelReplace® Conical Connection PMC NP 3.5x13mm
• 07332747073607: NobelReplace® Conical Connection PMC NP 3.5x16mm
• 07332747073591: NobelReplace® Conical Connection PMC RP 4.3x8mm
• 07332747073584: NobelReplace® Conical Connection PMC RP 4.3x10mm
• 07332747073577: NobelReplace® Conical Connection PMC RP 4.3x11.5mm
• 07332747073560: NobelReplace® Conical Connection PMC RP 4.3x13mm
• 07332747073553: NobelReplace® Conical Connection PMC RP 4.3x16mm
• 07332747073546: NobelReplace® Conical Connection PMC RP 5.0x8mm
• 07332747073539: NobelReplace® Conical Connection PMC RP 5.0x10mm
• 07332747073522: NobelReplace® Conical Connection PMC RP 5.0x11.5mm
• 07332747073515: NobelReplace® Conical Connection PMC RP 5.0x13mm
• 07332747073508: NobelReplace® Conical Connection PMC RP 5.0x16mm
• 07332747070385: Guided Counterbore NobelReplace® 6.0
• 07332747070378: Guided Counterbore NobelReplace® 5.0
• 07332747070361: Guided Counterbore NobelReplace® 4.3
• 07332747070354: Guided Counterbore NobelReplace® 3.5
• 07332747070293: NobelReplace® Tapered Guided Surgery Basic Kit
• 07332747037326: NobelReplace™ Tapered Surgery Kit - The kit includes instruments to perform implant surgery fo
• 07332747035773: NobelReplace® Conical Connection NP 3.5x8mm
• 07332747035766: NobelReplace® Conical Connection NP 3.5x10mm
• 07332747035759: NobelReplace® Conical Connection NP 3.5x11.5mm
• 07332747035742: NobelReplace® Conical Connection NP 3.5x13mm
• 07332747035735: NobelReplace® Conical Connection NP 3.5x16mm
• 07332747035728: NobelReplace® Conical Connection RP 4.3x8mm
• 07332747035711: NobelReplace® Conical Connection RP 4.3x10mm
• 07332747035704: NobelReplace® Conical Connection RP 4.3x11.5mm
• 07332747035698: NobelReplace® Conical Connection RP 4.3x13mm
• 07332747035681: NobelReplace® Conical Connection RP 4.3x16mm
• 07332747035674: NobelReplace® Conical Connection RP 5.0x8mm
• 07332747035667: NobelReplace® Conical Connection RP 5.0x10mm
• 07332747035650: NobelReplace® Conical Connection RP 5.0x11.5mm
• 07332747035643: NobelReplace® Conical Connection RP 5.0x13mm
• 07332747035636: NobelReplace® Conical Connection RP 5.0x16mm
• 07332747034141: NobelReplace PS NP 4.3x8mm
• 07332747034134: NobelReplace PS NP 4.3x10mm
• 07332747034127: NobelReplace PS NP 4.3x11.5mm
• 07332747034110: NobelReplace PS NP 4.3x13mm
• 07332747034103: NobelReplace PS NP 4.3x16mm
• 07332747034097: NobelReplace PS RP 5.0x8mm
• 07332747034080: NobelReplace PS RP 5.0x10mm
• 07332747034073: NobelReplace PS RP 5.0x11.5mm
• 07332747034066: NobelReplace PS RP 5.0x13mm
• 07332747034059: NobelReplace PS RP 5.0x16mm
• 07332747034042: NobelReplace PS WP 6.0x8mm
• 07332747034035: NobelReplace PS WP 6.0x10mm
• 07332747034028: NobelReplace PS WP 6.0x11.5mm
• 07332747034011: NobelReplace PS WP 6.0x13mm