HAPTITE s-Clean straight Fixture

GUDID 08806169108012

Dental Implant System / HAPTITE s-Clean straight Fixture D4.3mm X L7.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169108012
• NIH Device Record Key: db3981f2-9115-44c4-aded-e331f2d347eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAPTITE s-Clean straight Fixture
• Version Model Number: DSSF4307H
• 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	08806169108012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111364

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: 2019-05-08
• Device Publish Date: 2015-08-24

On-Brand Devices [HAPTITE s-Clean straight Fixture]

• 08806169108128: Dental Implant System / HAPTITE s-Clean straight Fixture D4.8mm X L16.0mm
• 08806169108111: Dental Implant System / HAPTITE s-Clean straight Fixture D4.8mm X L14.0mm
• 08806169108104: Dental Implant System / HAPTITE s-Clean straight Fixture D4.8mm X L12.0mm
• 08806169108098: Dental Implant System / HAPTITE s-Clean straight Fixture D4.8mm X L10.0mm
• 08806169108081: Dental Implant System / HAPTITE s-Clean straight Fixture D4.8mm X L8.0mm
• 08806169108074: Dental Implant System / HAPTITE s-Clean straight Fixture D4.8mm X L7.0mm
• 08806169108067: Dental Implant System / HAPTITE s-Clean straight Fixture D4.3mm X L16.0mm
• 08806169108050: Dental Implant System / HAPTITE s-Clean straight Fixture D4.3mm X L14.0mm
• 08806169108043: Dental Implant System / HAPTITE s-Clean straight Fixture D4.3mm X L12.0mm
• 08806169108036: Dental Implant System / HAPTITE s-Clean straight Fixture D4.3mm X L10.0mm
• 08806169108029: Dental Implant System / HAPTITE s-Clean straight Fixture D4.3mm X L8.0mm
• 08806169108012: Dental Implant System / HAPTITE s-Clean straight Fixture D4.3mm X L7.0mm
• 08806169108005: Dental Implant System / HAPTITE s-Clean straight Fixture D4.1mm X L16.0mm
• 08806169107992: Dental Implant System / HAPTITE s-Clean straight Fixture D4.1mm X L14.0mm
• 08806169107985: Dental Implant System / HAPTITE s-Clean straight Fixture D4.1mm X L12.0mm
• 08806169107978: Dental Implant System / HAPTITE s-Clean straight Fixture D4.1mm X L10.0mm
• 08806169107961: Dental Implant System / HAPTITE s-Clean straight Fixture D4.1mm X L8.0mm
• 08806169107954: Dental Implant System / HAPTITE s-Clean straight Fixture D4.1mm X L7.0mm
• 08806169162083: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169162052: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169162045: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169162014: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169162007: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161970: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161963: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161932: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161925: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161895: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161888: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161833: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161826: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161772: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161765: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161710: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161703: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)
• 08806169161659: Dental Implant System / HAPTITE s-Clean straight Type Set (Fixture + Cover Screw)