IH Wide Straight Abutment PDSL13

GUDID 07290117801604

R.D.J. TOV IMPLANT LTD

Dental implant system

• Primary Device ID: 07290117801604
• NIH Device Record Key: 25f12fd3-a4dc-4a73-9f8a-ddcd5fa72dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH Wide Straight Abutment
• Version Model Number: 13mm
• Catalog Number: PDSL13
• 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: false
• 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	07290117801604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240837

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

[07290117801604]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-25
• Device Publish Date: 2025-02-17

On-Brand Devices [IH Wide Straight Abutment]

• 07290117801604: 13mm
• 07290117801598: 11mm
• 07290117801581: 9mm