Dental 3D Planning Software
510(k) K113404
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113404 | Date6 Dec 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Dental Planning Software (Product Code: LLZ) designed for the visualization and segmentation of DICOM-compliant radiological data, including CT and Cone Beam CT scans. It generates 3D models of the oral maxillofacial region, enabling precise anatomical analysis and measurement capabilities such as distance, angle, and bone density assessments.
The software is intended for use by dentists and dental lab technicians in clinical settings, providing tools for 3D model creation compatible with CAD systems and rapid prototyping machines. Supplied as a digital product, it requires no sterility or single-use considerations. Authorized under FDA 510(k) clearance (K113404), it falls under the Radiology Advisory Committee’s review and is classified as a Class II X-ray system.
Questions
AI-generated answers, 19 Sep 2026
What types of radiological scans can this software process for dental planning?
This software is designed to work with DICOM-compliant radiological data, specifically CT scans and Cone Beam CT (CBCT) scans of the oral maxillofacial region. It enables visualization and segmentation of these scans to create detailed 3D models for precise anatomical analysis.
Is this software intended for use in clinical settings only, or can it also be used in dental labs?
The software is intended for use by both dentists in clinical settings and dental lab technicians. It provides tools for creating 3D models compatible with CAD systems and rapid prototyping machines, making it versatile for both environments.
How is this software supplied, and are there any sterility or single-use considerations?
This software is supplied as a digital product, meaning it is not a physical device and does not require sterility or single-use considerations. It is installed and used on compatible digital platforms.
What types of measurements and analyses can be performed with this software?
The software allows for precise anatomical analysis, including distance, angle, and bone density assessments. These capabilities are useful for detailed planning in dental procedures and treatments.
How was this software’s regulatory pathway determined, and which committee reviewed it?
This software was authorized under the FDA’s 510(k) clearance process (K113404) and is classified as a Class II X-ray system. It was reviewed by the Radiology Advisory Committee (RA) under the traditional clearance route, with a decision confirming substantial equivalence to a predicate device.