Cleared Traditional

K954722 - MICRO-DISPENSER 7000 & MICRODISPENSER 8000

K954722 is an FDA 510(k) clearance for MICRO-DISPENSER 7000 & MICRODISPENSER 8000, manufactured by NOUVAG AG. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K954722 · NOUVAG AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
95d
Days
Class 1
Risk

K954722 is an FDA 510(k) clearance for the MICRO-DISPENSER 7000 & MICRODISPENSER 8000. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by NOUVAG AG (Washington, US). The FDA issued a Cleared decision on January 16, 1996 after a review of 95 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.

FDA 510(k) Submission Details - K954722

510(k) Number K954722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1995
Decision Date January 16, 1996
Days to Decision 95 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
33d faster than avg
Panel avg: 128d · This submission: 95d
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 240
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K954722.
ALLRAP/SLIP-N-GRIP
K960352 · Dental Disposables Intl., Inc. · Feb 1996
SHORTSTOP DISPOSABLE PROPHY ANGLE
K955654 · Spintech, Inc. · Feb 1996
MTC 7707 HIGH SPEED AIR TURBINE
K945256 · Mtc Industries and Research, Ltd. · Jan 1996
PHASE CHANGE DENTAL LUBRICANT
K954991 · Phase Change · Jan 1996
DISPOSABLE PROPHY HANDPIECE
K954012 · Denticator Intl., Inc. · Nov 1995
W&H 900 INCOLIGHT LT HANDPIECE
K944718 · A-Dec, Inc. · Oct 1995
K954722 · MICRO-DISPENSER 7000 & MICRODISPENSER 8000
Download PDF FDA Summary NOUVAG AG