MEGA ISQ II Instrument 103100

GUDID 09010522002667

ISQ Measurement Instrument

Osstell AB

Dental implant stability resonance frequency analysis unit

• Primary Device ID: 09010522002667
• NIH Device Record Key: 68b6c306-d50a-4f9d-95d3-0deb01787907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEGA ISQ II Instrument
• Version Model Number: Osstell MEGA ISQ II Instrument
• Catalog Number: 103100
• Company DUNS: 633171269
• Company Name: Osstell AB
• 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	09010522002667 [Package]; Contains: 09010522002674; Package: Box [1 Units]; In Commercial Distribution
GS1	09010522002674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181888

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-06
• Device Publish Date: 2025-09-26

On-Brand Devices [MEGA ISQ II Instrument]

• 09010522001080: ISQ Measurement Instrument
• 09010522002667: ISQ Measurement Instrument