i-Clean tapered II Fixture

GUDID 08806169144461

Dental Implant System / i-Clean tapered II Fixture D3.7mm X L14.0mm

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169144461
• NIH Device Record Key: 213a11ba-046b-4a4e-a5c5-74c5f3deb5d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean tapered II Fixture
• Version Model Number: DI2FM3714
• Company DUNS: 694721181
• 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	08806169144461 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-27
• Device Publish Date: 2019-06-18

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

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• 08806169144461: Dental Implant System / i-Clean tapered II Fixture D3.7mm X L14.0mm
• 08806169144454: Dental Implant System / i-Clean tapered II Fixture D3.7mm X L12.0mm
• 08806169144447: Dental Implant System / i-Clean tapered II Fixture D3.7mm X L10.0mm
• 08806169144430: Dental Implant System / i-Clean tapered II Fixture D3.7mm X L8.0mm
• 08806169144416: Dental Implant System / i-Clean tapered II Fixture D4.7mm X L14.0mm
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• 08806169144348: Dental Implant System / i-Clean tapered II Fixture D4.3mm X L10.0mm
• 08806169144317: Dental Implant System / i-Clean tapered II Fixture D4.1mm X L14.0mm
• 08806169144300: Dental Implant System / i-Clean tapered II Fixture D4.1mm X L12.0mm
• 08806169144294: Dental Implant System / i-Clean tapered II Fixture D4.1mm X L10.0mm
• 08806169143440: Dental Implant System / i-Clean tapered II Fixture D3.7mm X L14.0mm
• 08806169143433: Dental Implant System / i-Clean tapered II Fixture D3.7mm X L12.0mm
• 08806169143426: Dental Implant System / i-Clean tapered II Fixture D3.7mm X L10.0mm
• 08806169124647: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
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• 08806169124593: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124586: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124579: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124555: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124548: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124531: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124524: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124500: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
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• 08806169124470: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124456: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)