Cleared Traditional

K912786 - W-H TOPAIR DENTAL HANDPIECE

K912786 is an FDA 510(k) clearance for W-H TOPAIR DENTAL HANDPIECE, manufactured by Sabra-The Dental Products Group. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K912786 · Sabra-The Dental Products Group · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
23d
Days
Class 1
Risk

K912786 is an FDA 510(k) clearance for the W-H TOPAIR DENTAL HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Sabra-The Dental Products Group (Skokie, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 23 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.

View all Sabra-The Dental Products Group devices

FDA 510(k) Submission Details - K912786

510(k) Number K912786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date July 17, 1991
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 127d · This submission: 23d
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 197
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K912786.
W&H 795 TOP AIR TURBINE SINGLE SPRAY
K944715 · A-Dec, Inc. · Jun 1995
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K944716 · A-Dec, Inc. · Jun 1995
W&H 798 TOP AIR TURBINE TRIPLE SPRAY
K944717 · A-Dec, Inc. · Jun 1995
OSTEOMED IB DRILL
K911937 · Osteomed Corp. · Jun 1991
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · Dentsply Intl. · Mar 1990