Cleared Traditional

K861328 - NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY

K861328 is an FDA 510(k) clearance for NEW BELMONT MODEL, manufactured by Belmont Equipment Corp.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K861328 · Belmont Equipment Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
15d
Days
Class 2
Risk

K861328 is an FDA 510(k) clearance for the NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Belmont Equipment Corp. (Somerset, US). The FDA issued a Cleared decision on April 24, 1986 after a review of 15 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 - K861328

510(k) Number K861328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1986
Decision Date April 24, 1986
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 32
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K861328.
TRIMODE SP DENTAL INTRA ORAL X-RAY
K896963 · Tempo Technology, Inc. · Jan 1990
VARIABLE KV INTREX VSK 60 - 90 KVP
K883354 · Keystone X-Ray, Inc. · Dec 1988
MINIM-X 2001-CIAS & MINIM-X 2002-CIAS
K882379 · Dentomar, Inc. · Sep 1988
PORTARAY
K792535 · Siemens Corp. · Jan 1980
RAFLEX 70
K792437 · Mdt Corp., Inc. · Jan 1980
GE-700 INTRA ORAL X-RAY SYSTEM
K781630 · General Electric Co. · Dec 1978
K861328 · NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY
Download PDF Belmont Equipment Cor…