← Back to catalogue

Atomica Planner

FDA UDI

Class II (US FDA UDI)

by Atomica Technology, Inc

Identity

Trade Name
Atomica Planner FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
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. FDA UDI
Model / Reference
v8 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860014198700 FDA UDI
510(k) Number
K230012 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic/craniofacial implantation planning software

Atomica Planner by Atomica Technology, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Atomica Technology, Inc

Sources (1)

  • FDA UDI eecc2070-4aca-4685-acf3-c62f1af60ead 35 fields · synced Jun 1, 2026