NeoTell 91060

GUDID 09010522002360

Osstell AB

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

• 09010522002469 - Neoss SmartPeg Mount: 2023-12-14 SmartPeg Mount
• 09010522002087 - Osstell SmartPeg Type 99: 2023-11-09
• 09010522002117 - Osstell SmartPeg Type 100: 2023-11-09 ISQ Measurement Peg
• 09010522002131 - Osstell SmartPeg Type 101: 2023-11-09 ISQ Measurement Peg
• 09010522002155 - Osstell SmartPeg Type 102: 2023-11-09 ISQ Measurement Peg
• 09010522002162 - Osstell SmartPeg Type 103: 2023-11-09 ISQ Measurement Peg
• 09010522002186 - Osstell SmartPeg Type 104: 2023-11-09 ISQ Measurement Peg
• 09010522002223 - Osstell SmartPeg Type 106: 2023-11-09 ISQ Measurement Peg