Data / Medical devices / United States / Atomica Technology, Inc

Atomica Technology, Inc: FDA-registered device maker in Atlanta, GA, United States, 1 510(k) clearance

Name: Atomica Technology, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Atomica Technology, Inc is registered with the FDA (registration 3030228551) in Atlanta, GA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 2, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3030228551
Address: 6445 Powers Ferry RD #360, Atlanta, GA, United States, 30339
Owner or operator: Atomica Technology, Inc (10089693)
Roles: Manufacturer
First device listed: December 28, 2023
Registered through: 2026
Brand names listed: 3Sixty, Surgical Guide, Anatomic Guide, Atomica CAD, Atomica Planner, Atomica Scanner, Atomica Software

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 2, 2023	K230012	Atomica Planner	LLZ	Substantially Equivalent	Atomica Technology, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 2, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.