Cleared Traditional

K083811 - W&H HANDPIECE ANESTO, MODEL: RA-5

K083811 is an FDA 510(k) clearance for W&H HANDPIECE ANESTO, manufactured by W&H Dentalwerk Buermoos GmbH. The device is a Class 2 Dental device with product code EGM cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K083811 · W&H Dentalwerk Buermoos GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
388d
Days
Class 2
Risk

K083811 is an FDA 510(k) clearance for the W&H HANDPIECE ANESTO, MODEL: RA-5. Classified as Injector, Jet, Mechanical-powered (product code EGM), Class II - Special Controls.

Submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on January 14, 2010 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4475 - 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. Elevated predicate reliance profile. 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 W&H Dentalwerk Buermoos GmbH devices

FDA 510(k) Submission Details - K083811

510(k) Number K083811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date January 14, 2010
Days to Decision 388 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
260d slower than avg
Panel avg: 128d · This submission: 388d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGM Device Classification - Class 2, Special Controls

Product Code EGM Injector, Jet, Mechanical-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4475
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 - EGM Injector, Jet, Mechanical-powered

Devices cleared under the same product code (EGM) and FDA review panel - the closest regulatory comparables to K083811.
QuickSleeper 5
K243427 · Dentalhitec · Aug 2025
CYBERJET LOCAL ANESTHESIA SYSTEM
K964802 · Intra Vantage, Inc. · May 1997
HYPODERMIC JET INJECTION APPARATUS
K962017 · American Jet Injector Corp. · Jul 1996
HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
K864294 · Smith & Nephew, Inc. · Nov 1987
MAYO SCISSOR STRAIGHT 6 3/4
K821273 · Conphar, Inc. · May 1982