MU Angled Abutment

GUDID 08806169113115

Ø4.8x6.08mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169113115
• NIH Device Record Key: 07d7f5f1-d54f-477d-a824-e609d923ae84
• Commercial Distribution Discontinuation: 2019-05-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MU Angled Abutment
• Version Model Number: DSMAA481730H
• 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	08806169113115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150344

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

Moist Heat or Steam Sterilization

[08806169113115]

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: 2015-08-29

On-Brand Devices [MU Angled Abutment]

• 08806169113146: Dental Implant System / s-Clean MU Angled Abutment D4.8mm, Angulation30°
• 08806169113115: Ø4.8x6.08mm