NovApex

GUDID 07290114350006

NovApex N-31 Apex Locator

FORUM ENGINEERING TECHNOLOGIES (96) LTD.

Endodontic apex locator

• Primary Device ID: 07290114350006
• NIH Device Record Key: 4f2b2bfd-1769-4698-a150-fb6799341571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovApex
• Version Model Number: N-31
• Company DUNS: 532219235
• Company Name: FORUM ENGINEERING TECHNOLOGIES (96) 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	07290114350006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121206

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-01
• Device Publish Date: 2023-12-24

Devices Manufactured by FORUM ENGINEERING TECHNOLOGIES (96) LTD.

• D100A102900000301 - PROPEX® Lip Clip: 2026-02-02 A stainless-steel accessory for apex localization which is used to complete the circuit between the endodontic file and patientâ
• D100A102900000401 - PROPEX® File Clip: 2026-02-02 An accessory for apex localization which is used to connect the endodontic file
• D100A103000000200 - Propex-Pixi Apex Locator: 2026-02-02 Propex-Pixi Apex Locator
• D100A103100000301 - Propex Pixi® Apex Locator Long measurement cable with clip: 2026-02-02 The measurement cable is connected at one end to the device and at the other end to the File-Clip and the Lip-Clip. Apex localiz
• D100B00XSAL000000 - X-Smart Apex Locator: 2026-02-02 X-Smart Apex Locator
• D100B00XSALAC1000 - X-Smart® Apex Locator Measurement cable: 2026-02-02 The measurement cable is connected at one end to the device and at the other end to the File-Clip and the Lip-Clip. Apex localiz
• D100B00XSALAC2000 - X-Smart® Apex Locator File clip: 2026-02-02 An accessory for apex localization which is used to connect the endodontic file
• D100B00XSALAC3000 - X-Smart® Apex Locator Lip clip: 2026-02-02 A stainless-steel accessory for apex localization which is used to complete the circuit between the endodontic file and patientâ