HAPTITE s-Clean SAVE Fixture

GUDID 08806169162151

Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169162151
• NIH Device Record Key: d0ce1b2e-9a03-4d1e-b0df-b137e75b1df4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAPTITE s-Clean SAVE Fixture
• Version Model Number: DSFS5512HS
• 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	08806169162151 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

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

• 08806169108500: Dental Implant System / HAPTITE s-Clean SAVE Fixture D7.0mm X L12.0mm
• 08806169108494: Dental Implant System / HAPTITE s-Clean SAVE Fixture D7.0mm X L10.0mm
• 08806169108487: Dental Implant System / HAPTITE s-Clean SAVE Fixture D7.0mm X L9.0mm
• 08806169108470: Dental Implant System / HAPTITE s-Clean SAVE Fixture D7.0mm X L8.0mm
• 08806169108463: Dental Implant System / HAPTITE s-Clean SAVE Fixture D7.0mm X L7.0mm
• 08806169108456: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.5mm X L12.0mm
• 08806169108449: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.5mm X L10.0mm
• 08806169108432: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.5mm X L9.0mm
• 08806169108425: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.5mm X L8.0mm
• 08806169108418: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.5mm X L7.0mm
• 08806169108401: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.0mm X L12.0mm
• 08806169108395: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.0mm X L10.0mm
• 08806169108388: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.0mm X L9.0mm
• 08806169108371: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.0mm X L8.0mm
• 08806169108364: Dental Implant System / HAPTITE s-Clean SAVE Fixture D6.0mm X L7.0mm
• 08806169108357: Dental Implant System / HAPTITE s-Clean SAVE Fixture D5.5mm X L12.0mm
• 08806169108340: Dental Implant System / HAPTITE s-Clean SAVE Fixture D5.5mm X L10.0mm
• 08806169108333: Dental Implant System / HAPTITE s-Clean SAVE Fixture D5.5mm X L9.0mm
• 08806169108326: Dental Implant System / HAPTITE s-Clean SAVE Fixture D5.5mm X L8.0mm
• 08806169108319: Dental Implant System / HAPTITE s-Clean SAVE Fixture D5.5mm X L7.0mm
• 08806169162403: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162373: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162366: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162335: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162328: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162298: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162281: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162250: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162243: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162212: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162205: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162199: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162182: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162175: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162168: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162151: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162144: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162137: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162120: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)
• 08806169162090: Dental Implant System / HAPTITE s-Clean SAVE Type Set (Fixture + Cover Screw)