s-Clean SAVE Fixture

GUDID 08806169105752

Dental Implant System / s-Clean SAVE Fixture D7.0mm X L7.4mm

DENTIS CO., LTD.

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• Primary Device ID: 08806169105752
• NIH Device Record Key: e51ff257-6198-4a5f-994a-25dd0d924ed4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean SAVE Fixture
• Version Model Number: DSFS7007
• 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	08806169105752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082843

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: 4
• Public Version Date: 2019-05-06
• Device Publish Date: 2015-08-20

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