s-Clean FreeMill Abutment

GUDID 08806169193100

Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169193100
• NIH Device Record Key: 6474d9b0-657e-4046-b1eb-225d3f5354b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean FreeMill Abutment
• Version Model Number: DSFMA5530HS
• 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	08806169193100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111364

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

[08806169193100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-31

On-Brand Devices [s-Clean FreeMill Abutment]

• 08806169110244: Dental Implant System / s-Clean FreeMill Abutment D7.5mm Cuff 3.8mm / Non-Hex / Non-Coating
• 08806169110237: Dental Implant System / s-Clean FreeMill Abutment D6.5mm Cuff 3.8mm / Non-Hex / Non-Coating
• 08806169110220: Dental Implant System / s-Clean FreeMill Abutment D5.5mm Cuff 2.8mm / Non-Hex / Non-Coating
• 08806169110213: Dental Implant System / s-Clean FreeMill Abutment D4.5mm Cuff 2.8mm / Non-Hex / Non-Coating
• 08806169110206: Dental Implant System / s-Clean FreeMill Abutment D4.0mm Cuff 2.8mm / Non-Hex / Non-Coating
• 08806169110190: Dental Implant System / s-Clean FreeMill Abutment D7.5mm Cuff 1.8mm / Non-Hex / Non-Coating
• 08806169110183: Dental Implant System / s-Clean FreeMill Abutment D6.5mm Cuff 1.8mm / Non-Hex / Non-Coating
• 08806169110176: Dental Implant System / s-Clean FreeMill Abutment D5.5mm Cuff 1.8mm / Non-Hex / Non-Coating
• 08806169110169: Dental Implant System / s-Clean FreeMill Abutment D4.5mm Cuff 1.8mm / Non-Hex / Non-Coating
• 08806169110152: Dental Implant System / s-Clean FreeMill Abutment D4.0mm Cuff 1.3mm / Non-Hex / Non-Coating
• 08806169110145: Dental Implant System / s-Clean FreeMill Abutment D7.5mm Cuff 3.8mm / Hex / Non-Coating
• 08806169110138: Dental Implant System / s-Clean FreeMill Abutment D6.5mm Cuff 3.8mm / Hex / Non-Coating
• 08806169110121: Dental Implant System / s-Clean FreeMill Abutment D5.5mm Cuff 2.8mm / Hex / Non-Coating
• 08806169110114: Dental Implant System / s-Clean FreeMill Abutment D4.5mm Cuff 2.8mm / Hex / Non-Coating
• 08806169110107: Dental Implant System / s-Clean FreeMill Abutment D4.0mm Cuff 2.8mm / Hex / Non-Coating
• 08806169110091: Dental Implant System / s-Clean FreeMill Abutment D7.5mm Cuff 1.8mm / Hex / Non-Coating
• 08806169110077: Dental Implant System / s-Clean FreeMill Abutment D5.5mm Cuff 1.8mm / Hex / Non-Coating
• 08806169110060: Dental Implant System / s-Clean FreeMill Abutment D4.5mm Cuff 1.8mm / Hex / Non-Coating
• 08806169110053: Dental Implant System / s-Clean FreeMill Abutment D4.0mm Cuff 1.3mm / Hex / Non-Coating
• 08806169193223: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193216: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193209: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193193: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193186: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193179: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193162: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193155: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193148: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193131: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193124: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193117: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193100: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193094: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193087: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193070: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193063: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193056: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193049: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169193032: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
• 08806169110084: Ø6.5, C:2.0 H:10mm