Cleared Traditional

K842788 - DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE

K842788 is the FDA 510(k) clearance for DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE by Brimms, Inc.. It is a Class 2 Neurology device (product code JXL) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K842788 · Brimms, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
50d
Days
Class 2
Risk

K842788 is an FDA 510(k) clearance for the DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Brimms, Inc. (Walker, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - the FDA neurology device 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.

View all Brimms, Inc. devices

Submission Details

510(k) Number K842788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date September 11, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 148d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXL Block, Bite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5070
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 Neurology devices follow this clearance model.

Regulatory Peers - JXL Block, Bite

All 9
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K842788.
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
OBERTO MOUTH PROP
K864962 · Medovations, Inc. · Feb 1987
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893 · Hi Chem, Inc. · Jun 1986
DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR
K830090 · Hudson Oxygen Therapy Sales Co. · Feb 1983
JACKSON BITE BLOCKS
K822018 · Kelleher Corp. · Aug 1982