DENTIN CLASSIC IMPLANTS

GUDID 07290113351295

Classic dental implant D=3.5mm, L=10mm

DENTIN IMPLANTS TECHNOLOGIES LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290113351295
• NIH Device Record Key: e7b5f689-f3dc-444c-aec3-4070f96e45cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTIN CLASSIC IMPLANTS
• Version Model Number: PRA-1033
• 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	07290113350298 [Primary]
GS1	07290113351295 [Package]; Contains: 07290113350298; 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 CLASSIC IMPLANTS]

• 07290113351547: Classic dental implant D=6.0mm, L=13mm
• 07290113351530: Classic dental implant D=6.0mm, L=11.5mm
• 07290113351523: Classic dental implant D=6.0mm, L=10mm
• 07290113351516: Classic dental implant D=6.0mm, L=8mm
• 07290113351509: Classic dental implant D=6.0mm, L=7mm
• 07290113351493: Classic dental implant D=6.0mm, L=6mm
• 07290113351486: Classic dental implant D=5.0mm, L=13mm
• 07290113351479: Classic dental implant D=5.0mm, L=11.5mm
• 07290113351462: Classic dental implant D=5.0mm, L=10mm
• 07290113351455: Classic dental implant D=5.0mm, L=8mm
• 07290113351448: Classic dental implant D=5.0mm, L=7mm
• 07290113351431: Classic dental implant D=5.0mm, L=6mm
• 07290113351424: Classic dental implant D=4.2mm, L=16mm
• 07290113351417: Classic dental implant D=4.2mm, L=13mm
• 07290113351400: Classic dental implant D=4.2mm, L=11.5mm
• 07290113351394: Classic dental implant D=4.2mm, L=10mm
• 07290113351387: Classic dental implant D=4.2mm, L=8mm
• 07290113351370: Classic dental implant D=3.8mm, L=16mm
• 07290113351363: Classic dental implant D=3.8mm, L=13mm
• 07290113351356: Classic dental implant D=3.8mm, L=11.5mm
• 07290113351349: Classic dental implant D=3.8mm, L=10mm
• 07290113351332: Classic dental implant D=3.8mm, L=8mm
• 07290113351325: Classic dental implant D=3.5mm, L=16mm
• 07290113351318: Classic dental implant D=3.5mm, L=13mm
• 07290113351301: Classic dental implant D=3.5mm, L=11.5mm
• 07290113351295: Classic dental implant D=3.5mm, L=10mm
• 07290113351288: Classic dental implant D=3.5mm, L=8mm