Neoss Implant System 31329

GUDID 05060440331497

31329 Neoss TiBase N (NB B 3.4 L)

Neoss Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 05060440331497
• NIH Device Record Key: a5e8b6ec-e849-4299-9bea-5f1a181ebb78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neoss Implant System
• Version Model Number: 31329
• Catalog Number: 31329
• Company DUNS: 216693627
• Company Name: Neoss Ltd
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Phone: 999-999-9999
• Email: contact.usa@neoss.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060440331497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150669

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

[05060440331497]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-27

On-Brand Devices [Neoss Implant System]

• 05060440333729: Neoss ScanPost S (Ø3.25 TiBase)
• 05060440333712: Neoss TiBase Ø3.25 (FX 3.4 S)
• 05060440333705: Access Impression Coping 13 mm and Replica
• 05060440333699: Access Abutment 6.0 mm
• 05060440333682: 51158 Drill – Sleeve Ø2.2 – 10 pcs
• 05060440333675: Access Abutment 30° 4.9 mm
• 05060440333668: Access Abutment 20° 4.6 mm
• 05060440333651: Access Abutment 10° 4.6 mm
• 05060440333644: 31365 ScanPeg – 5 pcs
• 05060440333637: 31364 Esthetic Healing Abutment with ScanPeg - Molar
• 05060440333620: 31363 Esthetic Healing Abutment with ScanPeg - Pre-molar
• 05060440333613: 31362 Esthetic Healing Abutment with ScanPeg - Canine
• 05060440333606: 31361 Esthetic Healing Abutment with ScanPeg - Narrow Incisor
• 05060440333590: 31360 Esthetic Healing Abutment with ScanPeg - Wide Incisor
• 05060440333583: Neoss iGO Screwdriver Machine 32mm
• 05060440333576: Neoss iGO Screwdriver Machine 22mm
• 05060440333569: Neoss iGO Laboratory Screw - 1 pc
• 05060440333552: Neoss iGO Abutment Screw - 1 pc
• 05060440333545: 90232 Neoss Equator Cap Tool
• 05060440333521: 64034 Tack and Screw Cassette
• 05060440333415: 90231 Neoss Equator Cap Removal Tool
• 05060440333408: 90230 Neoss Equator Cap Insertion Tool
• 05060440333392: 90222 Neoss Equator Protector Disk - 10 pcs
• 05060440333385: 90220 Neoss Equator Impression Coping & Replica – 2 sets
• 05060440333378: 90214 Neoss Equator Cap Extra Soft Retention, Yellow – 2 pcs
• 05060440333361: 90213 Neoss Equator Cap Soft Retention, Pink – 2 pcs
• 05060440333354: 90212 Neoss Equator Cap Strong Retention, Violet – 2 pcs
• 05060440333347: 90211 Neoss Equator Cap Standard Retention, White – 2 pcs
• 05060440333330: 90210 Neoss Equator Cap and Housing Kit
• 05060440333323: 90145 Clix Deactivating Tool
• 05060440333316: 90144 Clix Activating Tool
• 05060440333309: 90143 Clix Gold Housing
• 05060440333293: 90142 Clix Insertion Tool
• 05060440333286: 90141 Clix Insert Kit
• 05060440333279: 90140 Clix Ti Housing kit
• 05060440333248: 90132 Neoss LOCATOR® Driver Machine, 23 mm
• 05060440333231: 90131 Neoss LOCATOR® Driver Manual, 15 mm
• 05060440333224: 90130 Neoss LOCATOR® core tool
• 05060440333217: 90122 Neoss LOCATOR® block out spacer, 20 pcs
• 05060440333200: 90120 Neoss LOCATOR® Impression Coping and Replica
• 05060440333194: 90115 Neoss LOCATOR® Replacement Male, Extra Light Retention, Extended Range, Red, 2 pcs
• 05060440333187: 90114 Neoss LOCATOR® Replacement Male, Standard Retention, Extended Range, Green, 2 pcs
• 05060440333170: 90113 Neoss LOCATOR® Replacement Male, Extra Light Retention, Blue, 2 pcs
• 05060440333163: 90112 Neoss LOCATOR® Replacement Male, Light Retention, Pink, 2 pcs
• 05060440333156: 90111 Neoss LOCATOR® Replacement Male, Standard Retention, Clear, 2 pcs
• 05060440333149: 90110 Neoss Locator® Male Processing Kit
• 05060440333132: 90107 Access LOCATOR® Abutment Kit, 0.5 mm
• 05060440333125: Neoss LOCATOR® Abutment Kit 6 mm
• 05060440333118: Neoss LOCATOR® Abutment Kit 5 mm
• 05060440333101: Neoss LOCATOR® Abutment Kit 4 mm