NobelParallel™ 300072

GUDID 07332747124217

NobelParallel™ CC Tissue Collar RP 4.3 x 13+4.5mm

Nobel Biocare AB

Screw endosteal dental implant, two-piece

• Primary Device ID: 07332747124217
• NIH Device Record Key: 5689b76a-02f7-4b60-a2c5-969a46dc5367
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobelParallel™
• Version Model Number: 300072
• Catalog Number: 300072
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• Device Count: 1
• DM Exempt: true
• 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
• 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: 13 Millimeter
• Length: 13 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter
• Height: 4.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747124217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170135

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: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-05-24

On-Brand Devices [NobelParallel™]

• 07332747124491: Screw Tap NobelParallel™ Trefoil™ 5.5 x 11.5-13mm
• 07332747124484: Screw Tap NobelParallel™ Trefoil™ 5.0 x 11.5-13mm
• 07332747124477: Screw Tap NobelParallel™ Trefoil™ 4.3 x 11.5-13mm
• 07332747124255: NobelParallel™ CC Tissue Collar RP 5.5 x 13+4.5mm
• 07332747124248: NobelParallel™ CC Tissue Collar RP 5.5 x 11.5+4.5mm
• 07332747124231: NobelParallel™ CC Tissue Collar RP 5.0 x 13+4.5mm
• 07332747124224: NobelParallel™ CC Tissue Collar RP 5.0 x 11.5+4.5mm
• 07332747124217: NobelParallel™ CC Tissue Collar RP 4.3 x 13+4.5mm
• 07332747124200: NobelParallel™ CC Tissue Collar RP 4.3 x 11.5+4.5mm
• 07332747092776: NobelParallel™ Conical Connection Guided Surgery Kit
• 07332747092691: Guided Counterbore NobelParallel™ CC 5.5
• 07332747092684: Guided Counterbore NobelParallel™ CC 5.0
• 07332747092677: Guided Counterbore NobelParallel™ CC 4.3
• 07332747092660: Guided Counterbore NobelParallel™ CC 3.75
• 07332747092639: Guided Screw Tap NobelParallel™ CC 5.5 11.5-15mm
• 07332747092622: Guided Screw Tap NobelParallel™ CC 5.5 11.5-13mm
• 07332747092615: Guided Screw Tap NobelParallel™ CC 5.5 7-10mm
• 07332747092608: Guided Screw Tap NobelParallel™ CC 5.0 15-18mm
• 07332747092592: Guided Screw Tap NobelParallel™ CC 5.0 11.5-13mm
• 07332747092585: Guided Screw Tap NobelParallel™ CC 5.0 7-10mm
• 07332747092578: Guided Screw Tap NobelParallel™ CC 4.3 15-18mm
• 07332747092561: Guided Screw Tap NobelParallel™ CC 4.3 11.5-13mm
• 07332747092554: Guided Screw Tap NobelParallel™ CC 4.3 7-10mm
• 07332747092547: Guided Screw Tap NobelParallel™ CC 3.75 15-18mm
• 07332747092530: Guided Screw Tap NobelParallel™ CC 3.75 11.5-13mm
• 07332747092523: Guided Screw Tap NobelParallel™ CC 3.75 7-10mm
• 07332747091830: NobelParallel™ Conical Connection Surgery Kit. The kit includes instruments to perform implan
• 07332747091823: NobelParallel™ CC Cortical Drill 5.5mm
• 07332747091816: NobelParallel™ CC Cortical Drill 5.0mm
• 07332747091809: NobelParallel™ CC Cortical Drill 4.3mm
• 07332747091793: NobelParallel™ CC Cortical Drill 3.75mm
• 07332747091762: Screw Tap NobelParallel™ CC 5.5 7-15mm
• 07332747091755: Screw Tap NobelParallel™ CC 5.5 7-10mm
• 07332747091748: Screw Tap NobelParallel™ CC 5.0 7-18mm
• 07332747091731: NobelParallel CC WP 5.5x7mm
• 07332747091724: NobelParallel CC RP 5.0x18mm
• 07332747091717: NobelParallel CC RP 5.0x15mm
• 07332747091700: NobelParallel CC RP 5.0x13mm
• 07332747091649: Screw Tap NobelParallel™ CC 5.0 7-13mm
• 07332747091632: Screw Tap NobelParallel™ CC 4.3 7-18mm
• 07332747091625: Screw Tap NobelParallel™ CC 4.3 7-13mm
• 07332747091618: Screw Tap NobelParallel™ CC 3.75 7-18mm
• 07332747091601: Screw Tap NobelParallel™ CC 3.75 7-13mm
• 07332747091595: NobelParallel CC RP 5.0x11.5mm
• 07332747091588: NobelParallel CC RP 5.0x10mm
• 07332747091571: NobelParallel CC RP 5.0x8.5mm
• 07332747091564: NobelParallel CC RP 5.0x7mm
• 07332747091557: NobelParallel CC RP 4.3x18mm
• 07332747091540: NobelParallel CC RP 4.3x15mm
• 07332747091533: NobelParallel CC RP 4.3x13mm