Cleared Traditional

K792461 - CENTRIX MKIV ENDODONTIC DELIVERY

K792461 is an FDA 510(k) clearance for CENTRIX MKIV ENDODONTIC DELIVERY, manufactured by Centrix, Inc.. The device is a Class 1 Dental device with product code EIC cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K792461 · Centrix, Inc. · Dental device

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Dec 1979

Decision

16d

Days

Class 1

Risk

K792461 is an FDA 510(k) clearance for the CENTRIX MKIV ENDODONTIC DELIVERY. Classified as Syringe, Periodontic, Endodontic, Irrigating (product code EIC), Class I - General Controls.

Submitted by Centrix, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1979 after a review of 16 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K792461

510(k) Number	K792461 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 03, 1979
Decision Date	December 19, 1979
Days to Decision	16 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

112d faster than avg

Panel avg: 128d · This submission: 16d

Pathway characteristics

Predicate-based equivalence.

EIC Device Classification - Class 1, General Controls

Product Code	EIC Syringe, Periodontic, Endodontic, Irrigating
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 - EIC Syringe, Periodontic, Endodontic, Irrigating

All 13

Devices cleared under the same product code (EIC) and FDA review panel - the closest regulatory comparables to K792461.

WATER PISTOL

K811594 · Aus-Tex Dental Mfg. & Design · Jul 1981

MARK IV SYRINGE

K801483 · National Patent Development Corp. · Jul 1980

ROOT CANAL FILLING APPLICATOR NEEDLES

K801484 · National Patent Development Corp. · Jul 1980

GUTTA GUN

K771406 · Aus-Tex Dental Mfg. & Design · Aug 1977

SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE

K770967 · National Patent Development Corp. · Jun 1977

ENDOGATOR

K770813 · Aus-Tex Dental Mfg. & Design · May 1977

FDA 510(k) Resources - Dental

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K792461

Centrix, Inc.

Mchenry, IL · US

Regulatory profile

47 submissions 47 cleared

100% clearance rate · Active in Dental

View all devices by Centrix, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: December 19, 1979. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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510k Database

510(k) clearances indexed 176,583

Regulatory data since 1976

FDA monthly sync November 6, 2026