Cleared Traditional

K031851 - DENTISEPTIC HPC

K031851 is an FDA 510(k) clearance for DENTISEPTIC HPC, manufactured by Bethel, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K031851 · Bethel, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
46d
Days
Class 1
Risk

K031851 is an FDA 510(k) clearance for the DENTISEPTIC HPC. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Bethel, Inc. (Tyler, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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.

FDA 510(k) Submission Details - K031851

510(k) Number K031851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date August 01, 2003
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 128d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 253
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K031851.
CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS
K033213 · Codent Technical Industry Co., Ltd. · Feb 2004
PROPHY-MATE
K032395 · Nakanishi, Inc. · Oct 2003
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
K032234 · Mk-Dent GmbH · Oct 2003
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · Dentsply Intl. · Jul 2003
PROPHYPEARLS
K031868 · Kavo America · Jul 2003
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
K022535 · Microtech · Oct 2002
K031851 · DENTISEPTIC HPC
Download PDF FDA Summary Bethel, Inc.