Ragil Dental Implant RAGIL3.3L13

GUDID 07290117800485

R.D.J. TOV IMPLANT LTD

Dental implant system

• Primary Device ID: 07290117800485
• NIH Device Record Key: 04cc9bbb-d1a3-4439-a989-2d02362dedaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ragil Dental Implant
• Version Model Number: 3.3 x 13mm
• Catalog Number: RAGIL3.3L13
• Company DUNS: 600199501
• Company Name: R.D.J. TOV IMPLANT LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	07290117800485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240837

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: 2025-02-20
• Device Publish Date: 2025-02-12

On-Brand Devices [Ragil Dental Implant]

• 07290117800546: 3.75 x 16mm
• 07290117800539: 3.75 x 13mm
• 07290117800522: 3.75 x 11.5mm
• 07290117800515: 3.75 x 10mm
• 07290117800508: 3.75 x 8mm
• 07290117800492: 3.3 x 16mm
• 07290117800485: 3.3 x 13mm
• 07290117800478: 3.3 x 11.5mm
• 07290117800461: 3.3 x 10mm
• 07290117800454: 3.3 x 8mm