Cleared Traditional

K080738 - DENTRON SENSOR

K080738 is an FDA 510(k) clearance for DENTRON SENSOR, manufactured by Dentron Systems, LLC. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K080738 · Dentron Systems, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
57d
Days
Class 2
Risk

K080738 is an FDA 510(k) clearance for the DENTRON SENSOR. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Dentron Systems, LLC (Ormond Beach, US). The FDA issued a Cleared decision on May 13, 2008 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K080738

510(k) Number K080738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2008
Decision Date May 13, 2008
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 Peers - EAP Unit, X-ray, Intraoral

All 36
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K080738.
MEDICAL IMAGE PROCESSING UNIT
K113360 · Humanray Co,Ltd · Feb 2012
PROVU (TM) DENTAL X-RAY SYSTEM
K102573 · Advanced Image Science, Inc. · Jun 2011
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K093453 · Schick Technologies, Inc. · Nov 2009
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
K052422 · Flow X-Ray Corp. · Sep 2005
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K041385 · Schick Technologies, Inc. · Jun 2004
HELIODENT DS
K960819 · Pelton & Crane Co. · Mar 1996
K080738 · DENTRON SENSOR
Download PDF FDA Summary Dentron Systems, LLC