TCX Conical Dental Implant TCX5010

GUDID 07290117800416

R.D.J. TOV IMPLANT LTD

Dental implant system

• Primary Device ID: 07290117800416
• NIH Device Record Key: 90fc9332-f1a1-4f30-8944-d7529463ae39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TCX Conical Dental Implant
• Version Model Number: 5.0 x 10mm
• Catalog Number: TCX5010
• 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	07290117800416 [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: 2025-02-19
• Device Publish Date: 2025-02-11

On-Brand Devices [TCX Conical Dental Implant]

• 07290117800447: 5.0 x 16mm
• 07290117800430: 5.0 x 13mm
• 07290117800423: 5.0 x 11.5mm
• 07290117800416: 5.0 x 10mm
• 07290117800409: 5.0 x 8mm
• 07290117800386: 4.3 x 16mm
• 07290117800379: 4.3 x 13mm
• 07290117800362: 4.3 x 11.5mm
• 07290117800355: 4.3 x 10mm
• 07290117800348: 4.3 x 8mm
• 07290117800324: 3.5 x 16mm
• 07290117800317: 3.5 x 13mm
• 07290117800300: 3.5 x 11.5mm
• 07290117800294: 3.5 x 10mm
• 07290117800287: 3.5 x 8mm