s-Clean tapered Fixture

GUDID 08806169151827

Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment Screw)

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: 08806169151827
• NIH Device Record Key: 58ea599c-b35a-488b-ab69-869a0c36ba86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean tapered Fixture
• Version Model Number: DSFM3714M
• 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	08806169151827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150344

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: 2019-06-19
• Device Publish Date: 2019-06-11

On-Brand Devices [s-Clean tapered Fixture]

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• 08806169100917: Dental Implant System / s-Clean tapered Fixture D4.8mm X L12.0mm
• 08806169100900: Dental Implant System / s-Clean tapered Fixture D4.8mm X L10.0mm
• 08806169100894: Dental Implant System / s-Clean tapered Fixture D4.8mm X L8.0mm
• 08806169100887: Dental Implant System / s-Clean tapered Fixture D4.3mm X L14.0mm
• 08806169100870: Dental Implant System / s-Clean tapered Fixture D4.3mm X L12.0mm
• 08806169100863: Dental Implant System / s-Clean tapered Fixture D4.3mm X L10.0mm
• 08806169100856: Dental Implant System / s-Clean tapered Fixture D4.3mm X L8.0mm
• 08806169100849: Dental Implant System / s-Clean tapered Fixture D3.7mm X L14.0mm
• 08806169100832: Dental Implant System / s-Clean tapered Fixture D3.7mm X L12.0mm
• 08806169100825: Dental Implant System / s-Clean tapered Fixture D3.7mm X L10.0mm
• 08806169100818: Dental Implant System / s-Clean tapered Fixture D3.7mm X L8.0mm
• 08806169112996: Dental Implant System / s-Clean tapered Fixture D4.8mm X L7.0mm
• 08806169112989: Dental Implant System / s-Clean tapered Fixture D4.3mm X L7.0mm
• 08806169112972: Dental Implant System / s-Clean tapered Fixture D4.1mm X L14.0mm
• 08806169112965: Dental Implant System / s-Clean tapered Fixture D4.1mm X L12.0mm
• 08806169112958: Dental Implant System / s-Clean tapered Fixture D4.1mm X L10.0mm
• 08806169112941: Dental Implant System / s-Clean tapered Fixture D4.1mm X L8.0mm
• 08806169112934: Dental Implant System / s-Clean tapered Fixture D4.1mm X L7.0mm
• 08806169112927: Dental Implant System / s-Clean tapered Fixture D3.7mm X L7.0mm
• 08806169150943: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150936: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150929: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150912: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150905: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151094: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151087: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151070: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151063: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151056: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151049: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151032: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151025: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151018: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151001: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150998: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150981: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150974: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150967: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169150950: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169151933: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment
• 08806169151889: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment
• 08806169151872: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment
• 08806169151865: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment
• 08806169151858: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment
• 08806169151841: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment
• 08806169151834: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment
• 08806169151827: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment
• 08806169151780: Dental Implant System / s-Clean tapered Fixture Set (Fixture + Abutment + Cover Screw + Abutment