HAPTITE s-Clean tapered Fixture

GUDID 08806169161413

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

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169161413
• NIH Device Record Key: d876b0a9-02d0-493d-a6ca-6b833db49021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAPTITE s-Clean tapered Fixture
• Version Model Number: DSFR4310HS
• 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	08806169161413 [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 tapered Fixture]

• 08806169107749: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.8mm X L14.0mm
• 08806169107732: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.8mm X L12.0mm
• 08806169107725: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.8mm X L10.0mm
• 08806169107718: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.8mm X L8.0mm
• 08806169107701: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.8mm X L7.0mm
• 08806169107695: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.3mm X L14.0mm
• 08806169107688: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.3mm X L12.0mm
• 08806169107671: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.3mm X L10.0mm
• 08806169107664: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.3mm X L8.0mm
• 08806169107657: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.3mm X L7.0mm
• 08806169107640: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.1mm X L14.0mm
• 08806169107633: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.1mm X L12.0mm
• 08806169107626: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.1mm X L10.0mm
• 08806169107619: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.1mm X L8.0mm
• 08806169107602: Dental Implant System / HAPTITE s-Clean tapered Fixture D4.1mm X L7.0mm
• 08806169107596: Dental Implant System / HAPTITE s-Clean tapered Fixture D3.7mm X L14.0mm
• 08806169107589: Dental Implant System / HAPTITE s-Clean tapered Fixture D3.7mm X L12.0mm
• 08806169107572: Dental Implant System / HAPTITE s-Clean tapered Fixture D3.7mm X L10.0mm
• 08806169107565: Dental Implant System / HAPTITE s-Clean tapered Fixture D3.7mm X L8.0mm
• 08806169107558: Dental Implant System / HAPTITE s-Clean tapered Fixture D3.7mm X L7.0mm
• 08806169161642: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161598: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161581: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161536: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161529: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161475: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161468: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161413: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161406: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161352: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161345: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161291: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161284: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161239: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161222: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161178: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161161: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161116: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161109: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)
• 08806169161055: Dental Implant System / HAPTITE s-Clean tapered Type Set (Fixture + Cover Screw)