Cleared Traditional

K913974 - ACCESS IMPRESSION BARREL

K913974 is an FDA 510(k) clearance for ACCESS IMPRESSION BARREL, manufactured by Centrix, Inc.. The device is a Class 1 Dental device with product code EID cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K913974 · Centrix, Inc. · Dental device
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Feb 1992
Decision
172d
Days
Class 1
Risk

K913974 is an FDA 510(k) clearance for the ACCESS IMPRESSION BARREL. Classified as Syringe, Restorative And Impression Material (product code EID), Class I - General Controls.

Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on February 25, 1992 after a review of 172 days - an extended review 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: 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 Centrix, Inc. devices

FDA 510(k) Submission Details - K913974

510(k) Number K913974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date February 25, 1992
Days to Decision 172 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 127d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

EID Device Classification - Class 1, General Controls

Product Code EID Syringe, Restorative And Impression Material
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 - EID Syringe, Restorative And Impression Material

All 10
Devices cleared under the same product code (EID) and FDA review panel - the closest regulatory comparables to K913974.
BONE GRAFT DELIVERY SYRINGES
K941431 · Bio-Interfaces, Inc. · Jul 1994
CAULK'S VPS CARTRIDGE SYSTEM
K873153 · Dentsply Intl. · Sep 1987
IMPRESSION SYRINGE
K871937 · Dentsply Intl. · Jun 1987
CENTRIX RIBBON TUBES
K853282 · Centrix, Inc. · Aug 1985
UNITEK DISPOSABLE IMPRESSION SYRINGE
K851386 · Unitek Corp. · Apr 1985
G-C IMPRESSION SYRINGE
K812680 · G-C Intl. Corp. · Oct 1981