i-Clean SAVE II Fixture

GUDID 08806169144744

Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L12.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169144744
• NIH Device Record Key: 2b24d8fb-5d08-4ae6-8f4c-9a95ecebdd93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean SAVE II Fixture
• Version Model Number: DI2FS60121
• 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: true
• 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	08806169144744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-27
• Device Publish Date: 2019-06-19

On-Brand Devices [i-Clean SAVE II Fixture]

• 08806169123633: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123626: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123619: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123602: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123596: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123589: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123572: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123565: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123473: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123466: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123459: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123442: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123435: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123428: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123411: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169123404: Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
• 08806169144904: Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L12.0mm
• 08806169144898: Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L10.0mm
• 08806169144881: Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L8.0mm
• 08806169144874: Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L7.0mm
• 08806169144867: Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L12.0mm
• 08806169144850: Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L10.0mm
• 08806169144843: Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L8.0mm
• 08806169144744: Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L12.0mm
• 08806169144737: Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L10.0mm
• 08806169144720: Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L8.0mm
• 08806169144713: Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L7.0mm
• 08806169144706: Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L12.0mm
• 08806169144690: Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L10.0mm
• 08806169144683: Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L8.0mm
• 08806169144676: Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L7.0mm