osseolink Implant

GUDID 10816273020013

Implant 3.5mm x 11mm w Cover Screw

OSSEOLINK USA LLC

Screw endosteal dental implant, one-piece

• Primary Device ID: 10816273020013
• NIH Device Record Key: 8827a90c-7cf8-4791-9c47-d9cffb7df4ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: osseolink Implant
• Version Model Number: IMP3511
• Company DUNS: 080083007
• Company Name: OSSEOLINK USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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(877)677-3688
• Email: info@osseolink.com
• Phone: +1(877)677-3688
• Email: info@osseolink.com
• Phone: +1(877)677-3688
• Email: info@osseolink.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816273020016 [Primary]
GS1	10816273020013 [Package]; Contains: 00816273020016; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091878

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[10816273020013]

Radiation Sterilization

[10816273020013]

Radiation Sterilization

[10816273020013]

Radiation 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: 2016-09-05

On-Brand Devices [osseolink Implant]

• 00816273020757: Surgical Tray (no instruments)
• 00816273020740: Surgical Tray with Instrument set
• 00816273020733: Parallel Pin
• 00816273020726: Implant Placement Guide
• 00816273020719: Double Ended Depth Gauge
• 00816273020702: Driver Extension
• 00816273020696: Universal Implant Driver
• 00816273020689: Variable Torque Wrench
• 00816273020672: Driver Adapter
• 00816273020665: Hex Driver 0.05" (1.25 mm)
• 00816273020658: Tap Drill ø 5.0 mm
• 00816273020641: Tap Drill ø 4.0 mm
• 00816273020634: Tap Drill ø 3.5 mm
• 00816273020627: Countersink Drill ø 5.0 mm
• 00816273020610: Countersink Drill ø 4.5 mm
• 00816273020603: Countersink Drill ø 3.5 mm
• 00816273020597: Step Drill ø 5.0 mm
• 00816273020580: Step Drill ø 4.0 mm
• 00816273020573: Step Drill ø 3.5 mm
• 00816273020566: Drill- ø 2.8 mm-Short
• 00816273020559: Drill- ø 2.2 mm-Short
• 00816273020542: Drill-ø 4.9 mm-Long
• 00816273020535: Drill-ø 4.9 mm-Short
• 00816273020528: Drill-ø 4.3 mm-Long
• 00816273020511: Drill-ø 4.3 mm-Short
• 00816273020504: Drill-ø 3.9 mm-Long
• 00816273020498: Drill-ø 3.9 mm-Short
• 00816273020481: Drill-ø 3.3 mm-Long
• 00816273020474: Drill-ø 3.3 mm-Short
• 00816273020467: Drill- ø 2.5 mm-Long
• 00816273020450: Drill- ø 2.5 mm-Short
• 00816273020443: Drill- ø 2.0 mm-Long
• 00816273020436: Drill- ø 2.0 mm-Short
• 00816273020429: Lindemann Surgical Bur
• 00816273020412: Round Bur
• 00816273020405: Healing Abutments ø 6.0 mm,5.0 mm (H)
• 00816273020399: Healing Abutments ø 6.0 mm,3.0 mm (H)
• 00816273020382: Healing Abutments ø 5.0 mm,5.0 mm (H)
• 00816273020375: Healing Abutments ø 5.0 mm,3.0 mm (H)
• 00816273020368: Healing Abutments ø 4.0 mm,5.0 mm (H)
• 00816273020351: Healing Abutments ø 4.0 mm,3.0 mm (H)
• 00816273020344: Angled Abutment ø 5.5
• 00816273020337: Angled Abutment ø 4.5
• 00816273020320: Combination Abutment
• 00816273020313: Non anatomic Abutment-Titanium ø 5.5 mm,4.0 mm (H)
• 00816273020306: Non anatomic Abutment-Titanium ø 5.5 mm,0.5 mm (H)
• 00816273020290: Non anatomic Abutment-Titanium ø 5.5 mm,2.0 mm (H)
• 00816273020283: Non anatomic Abutment-Titanium ø 4.5 mm,4.0 mm (H)
• 00816273020276: Non anatomic Abutment-Titanium ø 4.5 mm, 0.5 mm (H)
• 00816273020269: Non anatomic Abutment-Titanium ø 4.5 mm,2.0 mm (H)