Cleared Traditional

K941856 - PREMIER PROMAX BITE GUARD

K941856 is an FDA 510(k) clearance for PREMIER PROMAX BITE GUARD, manufactured by Premier Dental Products Co.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K941856 · Premier Dental Products Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
355d
Days
Class 2
Risk

K941856 is an FDA 510(k) clearance for the PREMIER PROMAX BITE GUARD. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Philadelphia, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Premier Dental Products Co. devices

FDA 510(k) Submission Details - K941856

510(k) Number K941856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1994
Decision Date April 05, 1995
Days to Decision 355 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 148d · This submission: 355d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXL Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K941856.
VENTIL-A ORAL PROTECTOR
K992269 · Somatics, Inc. · Oct 1999
UNIVERSAL BITE BLOCK
K960663 · B&B Medical Technologies, Inc. · May 1996
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
TUM-E-VAC BITE BLOCK
K921946 · Ethox Corp. · Dec 1992
OBERTO MOUTH PROP
K864962 · Medovations, Inc. · Feb 1987