HAPTITE i-Clean SAVE Fixture

GUDID 08806169159137

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

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169159137
• NIH Device Record Key: a15daa81-13f5-4cc6-9d73-88900ba50bec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAPTITE i-Clean SAVE Fixture
• Version Model Number: DIFS6507HS
• 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	08806169159137 [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 i-Clean SAVE Fixture]

• 08806169107251: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.5mm X L7.0mm
• 08806169107244: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.0mm X L12.0mm
• 08806169107237: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.0mm X L10.0mm
• 08806169107220: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.0mm X L9.0mm
• 08806169107213: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.0mm X L8.0mm
• 08806169107206: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.0mm X L7.0mm
• 08806169107190: Dental Implant System / HAPTITE i-Clean SAVE Fixture D5.5mm X L12.0mm
• 08806169107183: Dental Implant System / HAPTITE i-Clean SAVE Fixture D5.5mm X L10.0mm
• 08806169107176: Dental Implant System / HAPTITE i-Clean SAVE Fixture D5.5mm X L9.0mm
• 08806169107169: Dental Implant System / HAPTITE i-Clean SAVE Fixture D5.5mm X L8.0mm
• 08806169107152: Dental Implant System / HAPTITE i-Clean SAVE Fixture D5.5mm X L7.0mm
• 08806169107343: Dental Implant System / HAPTITE i-Clean SAVE Fixture D7.0mm X L12.0mm
• 08806169107336: Dental Implant System / HAPTITE i-Clean SAVE Fixture D7.0mm X L10.0mm
• 08806169107329: Dental Implant System / HAPTITE i-Clean SAVE Fixture D7.0mm X L9.0mm
• 08806169107312: Dental Implant System / HAPTITE i-Clean SAVE Fixture D7.0mm X L8.0mm
• 08806169107305: Dental Implant System / HAPTITE i-Clean SAVE Fixture D7.0mm X L7.0mm
• 08806169107299: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.5mm X L12.0mm
• 08806169107282: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.5mm X L10.0mm
• 08806169107275: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.5mm X L9.0mm
• 08806169107268: Dental Implant System / HAPTITE i-Clean SAVE Fixture D6.5mm X L8.0mm
• 08806169159328: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159298: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159281: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159250: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159243: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159212: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159205: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159175: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159168: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159137: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159120: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159090: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169159083: Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)