Cleared Traditional

K870243 - BURNETT TMJ APPLIANCE

K870243 is an FDA 510(k) clearance for BURNETT TMJ APPLIANCE, manufactured by Medrad, Inc.. The device is a Class 2 Radiology device with product code EAG cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K870243 · Medrad, Inc. · Radiology device
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Feb 1987
Decision
34d
Days
Class 2
Risk

K870243 is an FDA 510(k) clearance for the BURNETT TMJ APPLIANCE. Classified as Cephalometer (product code EAG), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 24, 1987 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1830 - 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 - K870243

510(k) Number K870243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1987
Decision Date February 24, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAG Device Classification - Class 2, Special Controls

Product Code EAG Cephalometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1830
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 - EAG Cephalometer

All 9
Devices cleared under the same product code (EAG) and FDA review panel - the closest regulatory comparables to K870243.
DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM
K944162 · Teledyne Water Pik · Nov 1994
GX-C CEPHALOMETER
K920189 · Gendex Corp. · Apr 1992
DIGIGRAPH DIAGNOSTIC WORK/STATION
K896099 · Dolphin Imaging Systems · Jan 1991
GX CEPH
K842463 · Gendex Corp. · Aug 1984
CEPHALOMETER & FIXATOR
K833006 · Modern Systems, Inc. · Jan 1984
PLASTICEPH
K810538 · Morningstar Dental Co. · Apr 1981
K870243 · BURNETT TMJ APPLIANCE
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