AnyCheck

GUDID 08800038700000

AnyCheck IMT-100

DMS Co., Ltd.

Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit Dental implant stability measurement control unit

• Primary Device ID: 08800038700000
• NIH Device Record Key: afa48239-b7b3-4b2b-8ec1-d86746f6ab98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyCheck
• Version Model Number: IMT-100
• Company DUNS: 688444000
• Company Name: DMS Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	08800038700000 [Primary]
GS1	18800038700007 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180953

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

[08800038700000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-30
• Device Publish Date: 2020-06-17

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