DENTIN ONE PIECE IMPLANTS

GUDID 07290113351875

One Piece dental implant D=3.3mm, L=11.5mm

DENTIN IMPLANTS TECHNOLOGIES LTD

Screw endosteal dental implant, one-piece

• Primary Device ID: 07290113351875
• NIH Device Record Key: 2ac32079-5e0f-4f35-9766-09cff74a571e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTIN ONE PIECE IMPLANTS
• Version Model Number: DOP-1133
• 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	07290113350878 [Primary]
GS1	07290113351875 [Package]; Contains: 07290113350878; 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 ONE PIECE IMPLANTS]

• 07290113351899: One Piece dental implant D=3.3mm, L=16mm
• 07290113351882: One Piece dental implant D=3.3mm, L=13mm
• 07290113351875: One Piece dental implant D=3.3mm, L=11.5mm
• 07290113351868: One Piece dental implant D=3.3mm, L=10mm
• 07290113351851: One Piece dental implant D=3.0mm, L=16mm
• 07290113351844: One Piece dental implant D=3.0mm, L=13mm
• 07290113351837: One Piece dental implant D=3.0mm, L=11.5mm
• 07290113351820: One Piece dental implant D=3.0mm, L=10mm
• 07290113351813: One Piece dental implant D=2.5mm, L=16mm
• 07290113351806: One Piece dental implant D=2.5mm, L=13mm
• 07290113351790: One Piece dental implant D=2.5mm, L=11.5mm
• 07290113351783: One Piece dental implant D=2.5mm, L=10mm