Replace Select™ 37300

GUDID 07332747160802

Replace Select Tapered PMC NP 3.5x8mm

Nobel Biocare AB

Screw endosteal dental implant, two-piece

• Primary Device ID: 07332747160802
• NIH Device Record Key: cdc8e6be-e10b-4ba7-9fb8-dbdb018a8cf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Replace Select™
• Version Model Number: 37300
• Catalog Number: 37300
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Dimensions

• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 8 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747160802 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [Replace Select™]

• 07332747159974: Replace Select™ Tapered TiU 6.0 6.0x13mm
• 07332747159967: Replace Select™ Tapered TiU 6.0 6.0x10mm
• 07332747159721: Replace Select™ Tapered TiU WP 5.0x16mm
• 07332747159714: Replace Select™ Tapered TiU WP 5.0x13mm
• 07332747159707: Replace Select™ Tapered TiU WP 5.0x10mm
• 07332747159691: Replace Select™ Tapered TiU RP 4.3x16mm
• 07332747159684: Replace Select™ Tapered TiU RP 4.3x13mm
• 07332747159677: Replace Select™ Tapered TiU RP 4.3x10mm
• 07332747159660: Replace Select™ Tapered TiU NP 3.5x16mm
• 07332747159653: Replace Select™ Tapered TiU NP 3.5x13mm
• 07332747159646: Replace Select™ Tapered TiU NP 3.5x10mm
• 07332747160994: Replace Select™ Tapered PMC 6.0 6.0x16mm
• 07332747160987: Replace Select™ Tapered PMC 6.0 6.0x13mm
• 07332747160970: Replace Select™ Tapered PMC 6.0 6.0x11.5mm
• 07332747160963: Replace Select™ Tapered PMC 6.0 6.0x10mm
• 07332747160956: Replace Select™ Tapered PMC 6.0 6.0x8mm
• 07332747160949: Replace Select Tapered PMC WP 5.0x16mm
• 07332747160932: Replace Select Tapered PMC WP 5.0x13mm
• 07332747160925: Replace Select Tapered PMC WP 5.0x11.5mm
• 07332747160918: Replace Select Tapered PMC WP 5.0x10mm
• 07332747160901: Replace Select Tapered PMC WP 5.0x8mm
• 07332747160895: Replace Select Tapered PMC RP 4.3x16mm
• 07332747160888: Replace Select Tapered PMC RP 4.3x13mm
• 07332747160871: Replace Select Tapered PMC RP 4.3x11.5mm
• 07332747160864: Replace Select Tapered PMC RP 4.3x10mm
• 07332747160857: Replace Select Tapered PMC RP 4.3x8mm
• 07332747160840: Replace Select Tapered PMC NP 3.5x16mm
• 07332747160833: Replace Select Tapered PMC NP 3.5x13mm
• 07332747160826: Replace Select Tapered PMC NP 3.5x11.5mm
• 07332747160819: Replace Select Tapered PMC NP 3.5x10mm
• 07332747160802: Replace Select Tapered PMC NP 3.5x8mm
• 07332747160444: Replace Select™ TC RP 4.0x(15+3)mm
• 07332747160437: Replace Select™ TC RP 4.0x(13+3)mm
• 07332747160420: Replace Select™ TC RP 4.0x(10+3)mm
• 07332747160413: Replace Select™ TC RP 4.0x(7+3)mm
• 07332747160406: Replace Select™ TC NP 3.5x(15+3)mm
• 07332747160390: Replace Select™ TC NP 3.5x(13+3)mm
• 07332747160383: Replace Select™ TC NP 3.5x(10+3)mm
• 07332747160376: Replace Select™ TC NP 3.5x(7+3)mm
• 07332747160369: Replace Select™ Tapered TiU 6.0 6.0x11.5mm
• 07332747160352: Replace Select™ Tapered TiU 6.0 6.0x8mm
• 07332747160345: Replace Select™ Tapered TiU WP 5.0x11.5mm
• 07332747160338: Replace Select™ Tapered TiU WP 5.0x8mm
• 07332747160321: Replace Select™ Tapered TiU RP 4.3x11.5mm
• 07332747160314: Replace Select™ Tapered TiU RP 4.3x8mm
• 07332747160307: Replace Select™ Tapered TiU NP 3.5x11.5mm
• 07332747160291: Replace Select™ Tapered TiU NP 3.5x8mm