Cleared Traditional

K925829 - WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM

K925829 is an FDA 510(k) clearance for WAGGONER DENTAL MANUFACTURING STERIWATE..., manufactured by Waggoner Dental Mfg.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K925829 · Waggoner Dental Mfg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
88d
Days
Class 1
Risk

K925829 is an FDA 510(k) clearance for the WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Waggoner Dental Mfg. (Plano, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Waggoner Dental Mfg. devices

FDA 510(k) Submission Details - K925829

510(k) Number K925829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date February 12, 1993
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 189
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K925829.
A-DEC 2612 ASSISTANT'S CART
K933163 · A-Dec, Inc. · Oct 1993
A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)
K933165 · A-Dec, Inc. · Oct 1993
A-DEC 3127 ASSISTANT'S WALLMOUNT
K933168 · A-Dec, Inc. · Oct 1993
MDT/CASTLE PURUS DENTAL UNIT
K914697 · Mdt Corp., Inc. · Nov 1991
ASEPTIMINI UNIT, ADU-10
K905401 · Aseptico, Inc. · Feb 1991
ORAL PHARYNGEAL CLEANSING DEVICE
K905011 · Concord/Portex · Jan 1991