Cemented Octa Abutment

GUDID 08806169105301

Ø4.0, L:8.0mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169105301
• NIH Device Record Key: 297f477b-4b9d-471c-a149-35ef50bf4e8c
• Commercial Distribution Discontinuation: 2019-05-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cemented Octa Abutment
• Version Model Number: DECRM10
• 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	08806169105301 [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

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

Moist Heat or Steam Sterilization

[08806169105301]

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: 2015-08-07

On-Brand Devices [Cemented Octa Abutment]

• 08806169105417: Ø6.0, L:11.0mm
• 08806169105400: Ø6.0, L:10.0mm
• 08806169105394: Ø6.0, L:9.0mm
• 08806169105387: Ø6.0, L:8.0mm
• 08806169105370: Ø5.0, L:11.0mm
• 08806169105363: Ø5.0, L:10.0mm
• 08806169105356: Ø5.0, L:9.0mm
• 08806169105349: Ø5.0, L:8.0mm
• 08806169105332: Ø4.0, L:11.0mm
• 08806169105325: Ø4.0, L:10.0mm
• 08806169105318: Ø4.0, L:9.0mm
• 08806169105301: Ø4.0, L:8.0mm