Cleared Traditional

K880485 - XENEX DENTAL ROULETTE

K880485 is an FDA 510(k) clearance for XENEX DENTAL ROULETTE, manufactured by G & A Industries, Inc.. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K880485 · G & A Industries, Inc. · Dental device
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May 1988
Decision
88d
Days
Class 1
Risk

K880485 is an FDA 510(k) clearance for the XENEX DENTAL ROULETTE. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by G & A Industries, Inc. (East Brunswick, US). The FDA issued a Cleared decision on May 2, 1988 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 G & A Industries, Inc. devices

FDA 510(k) Submission Details - K880485

510(k) Number K880485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1988
Decision Date May 02, 1988
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EFW Device Classification - Class 1, General Controls

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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 - EFW Toothbrush, Manual

All 15
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K880485.
CREST TOOTHBRUSH WITH MICROSHIELD
K973236 · Procter & Gamble Co. · Mar 1998
REACH ANTIBACTERIAL TOOTHBRUSH
K971589 · Personal Products Co. · Jul 1997
ORALCHEK SUPER-SOFT BRUSH
K892264 · Pfizer, Inc. · Jun 1989
REACH* TOOTHBRUSH
K834580 · Johnson & Johnson Professionals, Inc. · Feb 1984
TOOTHBRUSH, REACH
K770749 · Johnson & Johnson Professionals, Inc. · Jun 1977
DENTAL STAIN REMOVER
K761352 · Concept, Inc. · Jan 1977