Cleared Traditional

K972023 - SLEEP-IN BONE SCREW SYSTEM

K972023 is an FDA 510(k) clearance for SLEEP-IN BONE SCREW SYSTEM, manufactured by Influence, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K972023 · Influence, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
84d
Days
Class 2
Risk

K972023 is an FDA 510(k) clearance for the SLEEP-IN BONE SCREW SYSTEM. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Influence, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 84 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 Influence, Inc. devices

FDA 510(k) Submission Details - K972023

510(k) Number K972023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date August 25, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
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 86
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K972023.
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
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RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · Respironics, Inc. · Feb 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · Respironics, Inc. · Feb 2004
TAP
K964516 · Nellcor Puritan Bennett, Inc. · Jan 1997
TAP ANTI-SNORING DEVICE
K962516 · Nellcor Puritan Bennett, Inc. · Sep 1996
ORTHODONTIC BITE
K922984 · American Orthodontics · Mar 1993