Integrity

GUDID 00850012724285

dental air Driven handpiece

Osseo Scientific LLC

Dental precision attachment fitting/adjustment tool

• Primary Device ID: 00850012724285
• NIH Device Record Key: 1f151aaf-d9b1-49da-a37c-8decf4649431
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity
• Version Model Number: NT-PG-III
• Company DUNS: 782849769
• Company Name: Osseo Scientific LLC
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(201)490-5421
• Email: mxf123@gmail.com
• Phone: +1(201)490-5421
• Email: mxf123@gmail.com
• Phone: +1(201)490-5421
• Email: mxf123@gmail.com
• Phone: +1(201)490-5421
• Email: mxf123@gmail.com
• Phone: +1(201)490-5421
• Email: mxf123@gmail.com
• Phone: +1(201)490-5421
• Email: mxf123@gmail.com
• Phone: +1(201)490-5421
• Email: mxf123@gmail.com
• Phone: +1(201)490-5421
• Email: mxf123@gmail.com
• Phone: +1(201)490-5421
• Email: mxf123@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012724285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070155

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[00850012724285]

Moist Heat or Steam Sterilization

[00850012724285]

Moist Heat or Steam Sterilization

[00850012724285]

Moist Heat or Steam Sterilization

[00850012724285]

Moist Heat or Steam Sterilization

[00850012724285]

Moist Heat or Steam Sterilization

[00850012724285]

Moist Heat or Steam Sterilization

[00850012724285]

Moist Heat or Steam Sterilization

[00850012724285]

Moist Heat or Steam Sterilization

[00850012724285]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [Integrity]

• 00850012724292: dental air Driven handpiece
• 00850012724285: dental air Driven handpiece
• 00850012724278: dental air Driven handpiece
• 00850012724261: dental Attachement
• 00850012724254: dental Attachement
• 00850012724247: dental Attachement
• 00850012724230: dental Attachement
• 00850012724223: dental Attachement
• 00850012724179: dental Attachement
• 00850012724162: dental Attachement
• 00850012724155: dental air Driven handpiece
• 00850012724148: dental air Driven handpiece
• 00850012724131: dental Attachement
• 00850012724216: dental air driven handpiece
• 00850012724209: dental air Driven handpiece