DENTIN PRESTIGE IMPLANTS

GUDID 07290113351684

Prestige dental implant D=5.0mm, L=10mm

DENTIN IMPLANTS TECHNOLOGIES LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290113351684
• NIH Device Record Key: f09a11ab-c3f5-49c2-a913-ebc3d5b98e65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTIN PRESTIGE IMPLANTS
• Version Model Number: PPR-1050
• Company DUNS: 600215680
• Company Name: DENTIN IMPLANTS TECHNOLOGIES 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290113350687 [Primary]
GS1	07290113351684 [Package]; Contains: 07290113350687; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120530

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: 2018-10-11
• Device Publish Date: 2018-09-10

On-Brand Devices [DENTIN PRESTIGE IMPLANTS]

• 07290113351776: Prestige dental implant D=6.0mm, L=13mm
• 07290113351769: Prestige dental implant D=6.0mm, L=11.5mm
• 07290113351752: Prestige dental implant D=6.0mm, L=10mm
• 07290113351745: Prestige dental implant D=6.0mm, L=8mm
• 07290113351738: Prestige dental implant D=6.0mm, L=7mm
• 07290113351721: Prestige dental implant D=6.0mm, L=6mm
• 07290113351714: Prestige dental implant D=5.0mm, L=16mm
• 07290113351707: Prestige dental implant D=5.0mm, L=13mm
• 07290113351691: Prestige dental implant D=5.0mm, L=11.5mm
• 07290113351684: Prestige dental implant D=5.0mm, L=10mm
• 07290113351677: Prestige dental implant D=5.0mm, L=8mm
• 07290113351660: Prestige dental implant D=5.0mm, L=7mm
• 07290113351653: Prestige dental implant D=5.0mm, L=6mm
• 07290113351646: Prestige dental implant D=4.2mm, L=16mm
• 07290113351639: Prestige dental implant D=4.2mm, L=13mm
• 07290113351622: Prestige dental implant D=4.2mm, L=11.5mm
• 07290113351615: Prestige dental implant D=4.2mm, L=10mm
• 07290113351608: Prestige dental implant D=4.2mm, L=8mm
• 07290113351592: Prestige dental implant D=3.8mm, L=16mm
• 07290113351585: Prestige dental implant D=3.8mm, L=13mm
• 07290113351578: Prestige dental implant D=3.8mm, L=11.5mm
• 07290113351561: Prestige dental implant D=3.8mm, L=10mm
• 07290113351554: Prestige dental implant D=3.8mm, L=8mm