Cleared Traditional

K885233 - NOVA DIAMOND

K885233 is an FDA 510(k) clearance for NOVA DIAMOND, manufactured by Microcopy, Div. Neo-Flo, Inc.. The device is a Class 1 Dental device with product code DZP cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K885233 · Microcopy, Div. Neo-Flo, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
55d
Days
Class 1
Risk

K885233 is an FDA 510(k) clearance for the NOVA DIAMOND. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Microcopy, Div. Neo-Flo, Inc. (Kennesaw, US). The FDA issued a Cleared decision on February 13, 1989 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4535 - 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 Microcopy, Div. Neo-Flo, Inc. devices

FDA 510(k) Submission Details - K885233

510(k) Number K885233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1988
Decision Date February 13, 1989
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 128d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

DZP Device Classification - Class 1, General Controls

Product Code DZP Instrument, Diamond, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4535
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 - DZP Instrument, Diamond, Dental

Devices cleared under the same product code (DZP) and FDA review panel - the closest regulatory comparables to K885233.
BLUWHITE DIAMOND DENTAL BURS MODIFIED
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K901967 · Micro-Aire Surgical Instruments, Inc. · Jul 1990
HYBRID POINTS
K854347 · Shofu Dental Corp. · Dec 1985
GINGI CURETTAGE DIAMOND POINTS
K832856 · Shofu Dental Corp. · Oct 1983
SUMMA DISK
K833038 · Shofu Dental Corp. · Oct 1983
TPE DIAMOND POINTS
K832855 · Shofu Dental Corp. · Sep 1983