DENTIN RAPID IMPLANTS

GUDID 07290113351127

Rapid dental implant D=4.2mm, L=10mm

DENTIN IMPLANTS TECHNOLOGIES LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290113351127
• NIH Device Record Key: 7d0094d6-d01d-4b3d-8354-8c4fb3866c89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTIN RAPID IMPLANTS
• Version Model Number: DCL-1042
• 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	07290113350120 [Primary]
GS1	07290113351127 [Package]; Contains: 07290113350120; 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 RAPID IMPLANTS]

• 07290113351271: Rapid dental implant D=6.0mm, L=13mm
• 07290113351264: Rapid dental implant D=6.0mm, L=11.5mm
• 07290113351257: Rapid dental implant D=6.0mm, L=10mm
• 07290113351240: Rapid dental implant D=6.0mm, L=8mm
• 07290113351233: Rapid dental implant D=6.0mm, L=7mm
• 07290113351226: Rapid dental implant D=6.0mm, L=6mm
• 07290113351219: Rapid dental implant D=5.0mm, L=13mm
• 07290113351202: Rapid dental implant D=5.0mm, L=11.5mm
• 07290113351196: Rapid dental implant D=5.0mm, L=10mm
• 07290113351189: Rapid dental implant D=5.0mm, L=8mm
• 07290113351172: Rapid dental implant D=5.0mm, L=7mm
• 07290113351165: Rapid dental implant D=5.0mm, L=6mm
• 07290113351158: Rapid dental implant D=4.2mm, L=16mm
• 07290113351141: Rapid dental implant D=4.2mm, L=13mm
• 07290113351134: Rapid dental implant D=4.2mm, L=11.5mm
• 07290113351127: Rapid dental implant D=4.2mm, L=10mm
• 07290113351110: Rapid dental implant D=4.2mm, L=8mm
• 07290113351103: Rapid dental implant D=4.2mm, L=6mm
• 07290113351097: Rapid dental implant D=3.8mm, L=16mm
• 07290113351080: Rapid dental implant D=3.8mm, L=13mm
• 07290113351073: Rapid dental implant D=3.8mm, L=11.5mm
• 07290113351066: Rapid dental implant D=3.8mm, L=10mm
• 07290113351059: Rapid dental implant D=3.8mm, L=8mm
• 07290113351042: Rapid dental implant D=3.5mm, L=16mm
• 07290113351035: Rapid dental implant D=3.5mm, L=13mm
• 07290113350021: Rapid dental implant D=3.5mm, L=11.5mm
• 07290113350014: Rapid dental implant D=3.5mm, L=10mm
• 07290113351004: Rapid dental implant D=3.5mm, L=8mm