i-Clean tapered II Fixture

GUDID 08806169124258

Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)

DENTIS CO., LTD.

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• Primary Device ID: 08806169124258
• NIH Device Record Key: 1f96281c-9d21-4a2c-b099-f1d88c13b047
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean tapered II Fixture
• Version Model Number: DI2FM37141S
• 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	08806169124258 [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: 2019-06-21
• Device Publish Date: 2019-06-13

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

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• 08806169124432: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124425: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124401: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
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• 08806169124302: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124296: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124289: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124258: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124241: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169124234: Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
• 08806169144614: Dental Implant System / i-Clean tapered II Fixture D4.7mm X L14.0mm
• 08806169144607: Dental Implant System / i-Clean tapered II Fixture D4.7mm X L12.0mm
• 08806169144591: Dental Implant System / i-Clean tapered II Fixture D4.7mm X L10.0mm
• 08806169144584: Dental Implant System / i-Clean tapered II Fixture D4.7mm X L8.0mm
• 08806169144560: Dental Implant System / i-Clean tapered II Fixture D4.3mm X L14.0mm
• 08806169144553: Dental Implant System / i-Clean tapered II Fixture D4.3mm X L12.0mm
• 08806169144546: Dental Implant System / i-Clean tapered II Fixture D4.3mm X L10.0mm
• 08806169144539: Dental Implant System / i-Clean tapered II Fixture D4.3mm X L8.0mm