Cleared Traditional

K981565 - BIOCLEAR CONCENTRATE

K981565 is an FDA 510(k) clearance for BIOCLEAR CONCENTRATE, manufactured by Waggoner Product Development. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K981565 · Waggoner Product Development · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
167d
Days
Class 1
Risk

K981565 is an FDA 510(k) clearance for the BIOCLEAR CONCENTRATE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Waggoner Product Development (Plano, US). The FDA issued a Cleared decision on October 15, 1998 after a review of 167 days - an extended review 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: 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 Waggoner Product Development devices

FDA 510(k) Submission Details - K981565

510(k) Number K981565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1998
Decision Date October 15, 1998
Days to Decision 167 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
40d slower than avg
Panel avg: 127d · This submission: 167d
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 124
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K981565.
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242 · Sirona Dental Systems GmbH · Dec 1998
ERADIC-ALL
K981171 · Theratechnologies, Inc. · Dec 1998
BIO-2000
K973765 · Micrylium Laboratories · Nov 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
ULTRACAM
K973410 · W. Edward Johansen · Oct 1998
CLEAN SOURCE I, MODEL CS1000
K981144 · Aquarius Technologies, Inc. · Sep 1998