Atomica Planner

GUDID 00860014198700

The Implant Planner Software is intended for use in importing, viewing, manipulating, segmenting, and analyzing medical imaging data from CT or CBCT scans to assist clinicians in dental implant planning. The software allows the user to virtually position dental implants in a 3D patient-specific model derived from DICOM images. It provides measurement tools, visualization features, and export functions to support the design of surgical guides or to facilitate the communication of the treatment plan to the surgical team. The software does not control or drive powered surgical instruments.

Atomica Technology, Inc.

Orthopaedic/craniofacial implantation planning software

• Primary Device ID: 00860014198700
• NIH Device Record Key: eecc2070-4aca-4685-acf3-c62f1af60ead
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atomica Planner
• Version Model Number: v8
• Company DUNS: 119502591
• Company Name: Atomica Technology, Inc.
• 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai
• Phone: +1 (770) 800-7495
• Email: support@atomica.ai

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014198700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230012

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2025-07-10
• Device Publish Date: 2025-07-02