s-Clean Hex Abutment

GUDID 08806169109798

Dental Implant System / s-Clean Hex Abutment D5.5mm X L11.8mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169109798
• NIH Device Record Key: 8e054453-9100-4b6e-b44e-524ab151f26c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Hex Abutment
• Version Model Number: DSHA553
• 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	08806169109798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171694

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

Moist Heat or Steam Sterilization

[08806169109798]

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: 2015-08-26

On-Brand Devices [s-Clean Hex Abutment]

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• 08806169109835: Dental Implant System / s-Clean Hex Abutment D6.0mm X L10.8mm
• 08806169109828: Dental Implant System / s-Clean Hex Abutment D6.0mm X L9.8mm
• 08806169109811: Dental Implant System / s-Clean Hex Abutment D5.5mm X L13.8mm
• 08806169109804: Dental Implant System / s-Clean Hex Abutment D5.5mm X L12.8mm
• 08806169109798: Dental Implant System / s-Clean Hex Abutment D5.5mm X L11.8mm
• 08806169109781: Dental Implant System / s-Clean Hex Abutment D5.5mm X L10.8mm
• 08806169109774: Dental Implant System / s-Clean Hex Abutment D5.5mm X L9.8mm
• 08806169109767: Dental Implant System / s-Clean Hex Abutment D4.8mm X L13.8mm
• 08806169109750: Dental Implant System / s-Clean Hex Abutment D4.8mm X L12.8mm
• 08806169109743: Dental Implant System / s-Clean Hex Abutment D4.8mm X L11.8mm
• 08806169109736: Dental Implant System / s-Clean Hex Abutment D4.8mm X L10.8mm
• 08806169109729: Dental Implant System / s-Clean Hex Abutment D4.8mm X L9.8mm
• 08806169109712: Dental Implant System / s-Clean Hex Abutment D4.5mm X L13.8mm
• 08806169109705: Dental Implant System / s-Clean Hex Abutment D4.5mm X L12.8mm
• 08806169109699: Dental Implant System / s-Clean Hex Abutment D4.5mm X L11.8mm
• 08806169109682: Dental Implant System / s-Clean Hex Abutment D4.5mm X L10.8mm
• 08806169109675: Dental Implant System / s-Clean Hex Abutment D4.5mm X L9.8mm
• 08806169172105: Dental Implant System / s-Clean Hex Abutment D6.0mm X L13.8mm