Cleared Traditional

K991857 - AIRFLOW HANDY

K991857 is an FDA 510(k) clearance for AIRFLOW HANDY, manufactured by Electro Medical Systems, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K991857 · Electro Medical Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
128d
Days
Class 1
Risk

K991857 is an FDA 510(k) clearance for the AIRFLOW HANDY. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Electro Medical Systems, Inc. (North Attleboro, US). The FDA issued a Cleared decision on October 7, 1999 after a review of 128 days - within the typical 510(k) review window.

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

View all Electro Medical Systems, Inc. devices

FDA 510(k) Submission Details - K991857

510(k) Number K991857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date October 07, 1999
Days to Decision 128 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
1d slower than avg
Panel avg: 127d · This submission: 128d
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 138
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K991857.
ATR 3000, ATR 2000, IMPLANT-PRO
K991401 · Advanced Technology Research (A.T.R.) S.R.P. · Dec 1999
LC COMPOSITE
K991492 · Harry J. Bosworth Co. · Dec 1999
ENDO-EZE MOTOR AND HANDPIECE
K992380 · Ultradent Products, Inc. · Oct 1999
SYNEA-HS HIGH SPEED-HANDPIECE
K992011 · A-Dec, Inc. · Sep 1999
MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)
K991701 · Nsk Nakanishi, Inc. · Aug 1999
ORL-E-92 SURGICAL DRILL SYSTEM
K984244 · Bien Air USA, Inc. · Feb 1999