FDA-cleared profile
Ewoosoft Co., Ltd
Authorized purpose: Ez3D-i/E3 provides dental and maxillofacial DICOM viewing, three-dimensional visualization, multiplanar reconstruction, two-dimensional analysis, implant simulation, canal tracing, and bone-density tools for trained radiologists and dentists.
Product overview
Authorized purpose: Ez3D-i/E3 provides dental and maxillofacial DICOM viewing, three-dimensional visualization, multiplanar reconstruction, two-dimensional analysis, implant simulation, canal tracing, and bone-density tools for trained radiologists and dentists.
Overview status: Source-reviewed overview
Clinical role: Ez3D-i/E3 provides dental and maxillofacial DICOM viewing, three-dimensional visualization, multiplanar reconstruction, two-dimensional analysis, implant simulation, canal tracing, and bone-density tools for trained radiologists and dentists.
Evidence from the reviewed source record: K231757 reports DICOM loading, viewing, MPR, three-dimensional analysis, implant and canal tools, measurements, and software validation for dental CT, panoramic, cephalometric, and intraoral image workflows. No product-specific clinical outcome or diagnostic-performance metric is established in the public FDA summary.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The packet names trained medical professionals such as radiologists and dentists; it does not establish the broader role list in the current value.
This is the packet's direct input description; cone-beam CT is not stated.
The exact packet supports these visualization, analysis, MPR, implant, canal, and bone-density functions; surgical-guide inputs and reports are not stated.
This replaces the current clinical-examination and surgical-judgment wording with the packet's explicit adjunctive-use boundary.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
The exact packet states these imaging sources and does not use the current CBCT-only modality value. Controlled directory display reconciled from exact FDA wording: CT, panorama, cephalometric, and intraoral imaging. -> CBCT.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K231757 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
DICOM import and export to dental workstations, PACS, laboratory, or guide-manufacturing workflows; validate patient identity, orientation, voxel geometry, measurements, and export.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. The capability is derived from the exact FDA workflow and still requires local acceptance testing.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Use only supported dental image types and planning functions. Implant, canal, and bone-density outputs require review by the treating dental professional and do not replace clinical examination or surgical judgment.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use only supported dental image types and planning functions. Implant, canal, and bone-density outputs require review by the treating dental professional and do not replace clinical examination or surgical judgment.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. The capability is derived from the exact FDA workflow and still requires local acceptance testing.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K231757
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
3 unlinked candidate evidence records are retained for source review and excluded from this evidence display.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 5 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 5 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, anatomy, modality, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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