Neoss Implant System 31395

GUDID 05060440335457

NeoBase® Mono SSC G0.3 mm – H5.6 mm

Neoss AB

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 05060440335457
• NIH Device Record Key: eb72ecac-9252-4d51-a9da-80a4efa801e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neoss Implant System
• Version Model Number: 31395
• Catalog Number: 31395
• Company DUNS: 509583543
• Company Name: Neoss 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: true
• Expiration Date: false
• 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: 999-999-9999
• Email: contact.usa@neoss.com
• Phone: 999-999-9999
• Email: contact.usa@neoss.com
• Phone: 999-999-9999
• Email: contact.usa@neoss.com
• Phone: 999-999-9999
• Email: contact.usa@neoss.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060440335457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043195

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05060440335457]

Moist Heat or Steam Sterilization

[05060440335457]

Moist Heat or Steam Sterilization

[05060440335457]

Moist Heat or Steam Sterilization

[05060440335457]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-10
• Device Publish Date: 2020-11-02

On-Brand Devices [Neoss Implant System]

• 05060440335501: NeoBase® Multi SSC G0.3 mm - H3.6 mm, NP
• 05060440335495: NeoBase® Mono SSC G0.3 mm - H5.6 mm, NP
• 05060440335488: NeoBase® Mono SSC G0.3 mm - H3.6 mm, NP
• 05060440335471: NeoBase® Multi SSC G0.3 mm – H3.6 mm
• 05060440335464: NeoBase® Mono SSC G1.5 mm – H5.6 mm
• 05060440335457: NeoBase® Mono SSC G0.3 mm – H5.6 mm
• 05060440335440: NeoBase® Mono SSC G1.5 mm – H3.6 mm
• 05060440335433: NeoBase® Mono SSC G0.3 mm – H3.6 mm
• 05060440334290: Membrane Screw 3 mm - 10 pcs
• 05060440334283: Membrane Tack 3 mm - 10 pcs
• 05060440334436: Countersink Edge Ø5.0
• 05060440334429: Countersink Edge Ø4.5
• 05060440334412: Countersink Edge Ø4.0
• 05060440334405: Countersink Edge Ø3.5
• 05060440335341: Neoss Equator Cap and Housing Kit - Extended Divergence
• 05060440335266: Neoss NT Blanks CoCr SSC, Ø12 mm, NP – 5 pc
• 05060440335259: Neoss NT Blanks Ti SSC, Ø12 mm, NP – 5 pc
• 05060440334979: Neoss NT Blank CoCr SSC, Ø12 mm, NP – 1 pc
• 05060440334962: Neoss NT Blank Ti SSC, Ø12 mm, NP – 1 pc
• 05060440334948: Neoss NT Blank Ti SSC, Ø12 mm, SP – 1 pc
• 05060440335686: Direction/Depth Gauge – 4 pcs
• 05060440335334: Bone Remover Cover Screw, NP
• 05060440335327: Bone Remover Cover Screw, SP
• 05060440335310: Bone Profiler Ø4.1 mm, NP
• 05060440335303: Bone Profiler Ø6.6 mm, SP
• 05060440335297: Bone Profiler Ø5.1 mm, SP
• 05060440335228: Drill Kit, Edge Implants Ø3.5-5.0
• 05060440335211: Drill Kit, Tapered Implants Ø3.5-5.5
• 05060440335204: Supplementary Drill Kit
• 05060440335198: Drill Kit, Straight Implants Ø3.5-4.5
• 05060440335174: Twist Drill, Tapered Ø5.5 x 7-17 mm
• 05060440334917: Twist Drill, Tapered Ø4.9 x 7-17 mm
• 05060440334900: Twist Drill, Tapered Ø4.4 x 7-17 mm
• 05060440334894: Twist Drill, Tapered Ø3.9 x 7-17 mm
• 05060440335129: Twist Drill, Tapered Ø3.4 x 7-17 mm
• 05060440334870: Twist Drill, Tapered Ø3.0 x 7-17 mm
• 05060440334863: Twist Drill, Straight Ø5.1 x 7-17 mm
• 05060440334856: Twist Drill, Straight Ø4.9 x 7-17 mm
• 05060440334849: Twist Drill, Straight Ø4.6 x 7-17 mm
• 05060440334832: Twist Drill, Straight Ø4.4 x 7-17 mm
• 05060440334825: Twist Drill, Straight Ø4.1 x 7-17 mm
• 05060440334818: Twist Drill, Straight Ø3.9 x 7-17 mm
• 05060440334801: Twist Drill, Straight Ø3.6 x 7-17 mm
• 05060440334795: Twist Drill, Straight Ø3.4 x 7-17 mm
• 05060440334788: Twist Drill, Straight Ø3.2 x 7-17 mm
• 05060440334771: Twist Drill, Straight Ø3.0 x 7-17 mm
• 05060440334764: Twist Drill, Straight Ø2.85 x 7-17 mm
• 05060440334757: Twist Drill, Straight Ø2.2 x 7-17 mm
• 05060440332692: Neoss® Guide – Implant Inserter, SP
• 05060440335280: Neoss NT Blanks CoCr SSC, Ø16 mm, SP – 5 pc