Cleared Traditional

K934002 - PERIO/ENDO LENS

K934002 is an FDA 510(k) clearance for PERIO/ENDO LENS, manufactured by New Image Industries, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K934002 · New Image Industries, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
172d
Days
Class 1
Risk

K934002 is an FDA 510(k) clearance for the PERIO/ENDO LENS. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by New Image Industries, Inc. (Newport Beach, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 172 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 New Image Industries, Inc. devices

FDA 510(k) Submission Details - K934002

510(k) Number K934002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1993
Decision Date February 04, 1994
Days to Decision 172 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 127d · This submission: 172d
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 154
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K934002.
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K922651 · Ace Surgical Supply Co., Inc. · Jan 1994