NeoTell 91060

GUDID 09010522002360

Osstell AB

Dental implant stability measurement control unit

• Primary Device ID: 09010522002360
• NIH Device Record Key: 4f1f40b1-f1b5-4f84-9dff-64aa9815d84c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoTell
• Version Model Number: NeoTell
• Catalog Number: 91060
• Company DUNS: 633171269
• Company Name: Osstell AB
• 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: 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	09010522002360 [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: 2023-07-11
• Device Publish Date: 2023-07-03

Devices Manufactured by Osstell AB

• 09010522000731 - Osstell ISQ Probe: 2024-09-19 ISQ Measurement Instrument Accessory
• 09010522002315 - Osstell SmartPeg Type 110: 2024-09-19 ISQ Measurement Peg
• 09010522002322 - Osstell SmartPeg Type 111: 2024-09-19 ISQ Measurement Peg
• 09010522000847 - Osstell IDx Instrument: 2024-06-04 ISQ Measurement Instrument
• 09010522001134 - DIO IDx Instrument: 2024-06-04 ISQ Measurement Instrument
• 09010522002476 - SmartPeg Type 117: 2024-05-23 ISQ Measurement Peg
• 09010522002070 - SmartPeg Type 98 - Neoss: 2024-05-22 ISQ Measurement Peg
• 09010522002469 - Neoss SmartPeg Mount: 2023-12-14 SmartPeg Mount