Cleared Traditional

K955822 - REMOVABLE HERBST APPLIANCE

K955822 is an FDA 510(k) clearance for REMOVABLE HERBST APPLIANCE, manufactured by Univ. Dental Assoc. Department of Orthodontics. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K955822 · Univ. Dental Assoc. Department of Orthodontics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
85d
Days
Class 2
Risk

K955822 is an FDA 510(k) clearance for the REMOVABLE HERBST APPLIANCE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Univ. Dental Assoc. Department of Orthodontics (Buffalo, US). The FDA issued a Cleared decision on March 20, 1996 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory 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 Univ. Dental Assoc. Department of Orthodontics devices

FDA 510(k) Submission Details - K955822

510(k) Number K955822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date March 20, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 Dental devices follow this clearance model.

Regulatory Peers - LRK Device, Anti-snoring

All 113
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K955822.
SNORE TEC
K963063 · Marketing Technologies, Inc. · Apr 1997
TAP
K964516 · Nellcor Puritan Bennett, Inc. · Jan 1997
TAP ANTI-SNORING DEVICE
K962516 · Nellcor Puritan Bennett, Inc. · Sep 1996
SNOREFREE
K955336 · Scott Feldman Dds & Norman Shapiro Dds · Jan 1996
ORTHODONTIC BITE
K922984 · American Orthodontics · Mar 1993