ChecQ

GUDID 08800053084123

ISQ measurement device

DENTIS CO. ,LTD

Dental implant stability resonance frequency analysis unit

• Primary Device ID: 08800053084123
• NIH Device Record Key: 3d02412c-69d6-4847-971e-2ab76971d7da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChecQ
• Version Model Number: AC100
• Company DUNS: 694721181
• Company Name: DENTIS CO. ,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	08800053084123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241065

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: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by DENTIS CO. ,LTD

• 08800053084123 - ChecQ: 2025-04-08ISQ measurement device
• 08800053084123 - ChecQ: 2025-04-08 ISQ measurement device
• 08800053092494 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092500 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092517 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092524 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092531 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092548 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092555 - ChecQPEG: 2025-04-08 ISQ meausrement PEG