2i Wide Cemented Abutment

GUDID 08806169105158

Ø6.0, L:7.0mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169105158
• NIH Device Record Key: a1e2fc3e-ddad-4fc6-b8e2-bf22226b62bb
• Commercial Distribution Discontinuation: 2019-05-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 2i Wide Cemented Abutment
• Version Model Number: TECAW616H
• Company DUNS: 688204158
• Company Name: DENTIS CO., 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169105158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082843

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

[08806169105158]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-07-30

On-Brand Devices [2i Wide Cemented Abutment]

• 08806169105295: Ø6.0, L:12.0mm
• 08806169105288: Ø6.0, L:12.0mm
• 08806169105271: Ø6.0, L:11.0mm
• 08806169105264: Ø6.0, L:11.0mm
• 08806169105257: Ø6.0, L:10.0mm
• 08806169105240: Ø6.0, L:10.0mm
• 08806169105233: Ø6.0, L:9.0mm
• 08806169105226: Ø6.0, L:9.0mm
• 08806169105219: Ø6.0, L:10.0mm
• 08806169105202: Ø6.0, L:10.0mm
• 08806169105196: Ø6.0, L:9.0mm
• 08806169105189: Ø6.0, L:9.0mm
• 08806169105172: Ø6.0, L:8.0mm
• 08806169105165: Ø6.0, L:8.0mm
• 08806169105158: Ø6.0, L:7.0mm
• 08806169105141: Ø6.0, L:7.0mm