I-FIX O-Ring Cap

GUDID 08806169104311

Dental Implant System / I-FIX O-Ring Cap D4.8mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806169104311
• NIH Device Record Key: 89d92817-52b3-4cda-aa27-8e6b485db871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-FIX O-Ring Cap
• Version Model Number: DOC
• 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	08806169104311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083586

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-08
• Device Publish Date: 2015-08-26

Devices Manufactured by DENTIS CO., LTD.

• 08800053035163 - s-Clean SQ-SL Fixture: 2021-03-10 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
• 08800053022385 - s-Clean SQ-SL Fixture: 2021-03-08 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
• 08806169155979 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1 X L7.0 mm
• 08806169155986 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L7.5mm
• 08806169155993 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L9.5mm
• 08806169156006 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L11.5mm
• 08806169156013 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L13.5mm
• 08806169156020 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.4mm X L7.0mm