Cleared Traditional

K042212 - IMPLANTMASTER

K042212 is an FDA 510(k) clearance for IMPLANTMASTER, manufactured by I-Dent. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K042212 · I-Dent · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
66d
Days
Class 2
Risk

K042212 is an FDA 510(k) clearance for the IMPLANTMASTER. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by I-Dent (Hod Hasharon, IL). The FDA issued a Cleared decision on October 21, 2004 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

FDA 510(k) Submission Details - K042212

510(k) Number K042212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2004
Decision Date October 21, 2004
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K042212.
IMAGE MEDICAL ACQUISITION STATION (IMAS)
K042700 · Erad Imagemedical Corp. · Nov 2004
PHILIPS ORTHOPAEDIC APPLICATIONS
K042867 · Philips Medical Systems North America, Inc. · Nov 2004
SIENET COSMOS (VERSION V15A)
K042832 · Siemens AG Medical Solutions · Oct 2004
RSA-CMS
K042383 · Medis Medical Imaging Systems BV · Oct 2004
IPACS CARDIO
K042781 · Realtimeimage, Inc. · Oct 2004
WIDE 1MP LCD MONITOR SYSTEM
K042634 · Wide Corporation · Oct 2004
K042212 · IMPLANTMASTER
Download PDF FDA Summary I-Dent