s-Clean FreeMill Abutment

GUDID 08806169193193

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

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169193193
• NIH Device Record Key: a441a999-bddb-4cb6-b133-a3b48a8d580e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean FreeMill Abutment
• Version Model Number: DSFMA4530NS
• 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	08806169193193 [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

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

Moist Heat or Steam Sterilization

[08806169193193]

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