Cleared Traditional

K833285 - RX IV PENTRON IV

K833285 is an FDA 510(k) clearance for RX IV PENTRON IV, manufactured by Genesis Industries, Inc.. The device is a Class 1 Dental device with product code EIS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K833285 · Genesis Industries, Inc. · Dental device
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Dec 1983
Decision
91d
Days
Class 1
Risk

K833285 is an FDA 510(k) clearance for the RX IV PENTRON IV. Classified as Remover, Crown (product code EIS), Class I - General Controls.

Submitted by Genesis Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Genesis Industries, Inc. devices

FDA 510(k) Submission Details - K833285

510(k) Number K833285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1983
Decision Date December 22, 1983
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

EIS Device Classification - Class 1, General Controls

Product Code EIS Remover, Crown
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EIS Remover, Crown

All 14
Devices cleared under the same product code (EIS) and FDA review panel - the closest regulatory comparables to K833285.
C & B 61 PENTRON C & B61
K833289 · Genesis Industries, Inc. · Dec 1983
GOLD-PALLADIUM-SILVER BASED CAST/ALLOY
K833736 · Jeneric Ind. · Dec 1983
SUPRA AP CHOICE 83
K833280 · Genesis Industries, Inc. · Dec 1983
C & B57 PENTRON C & B57
K833288 · Genesis Industries, Inc. · Dec 1983
NATURELLE-LITE
K833279 · Genesis Industries, Inc. · Nov 1983
RX D PENTRON
K833281 · Genesis Industries, Inc. · Nov 1983