Cleared Traditional

K811582 - THE PLACER

K811582 is an FDA 510(k) clearance for THE PLACER, manufactured by Cavitron Corp.. The device is a Class 1 Dental device with product code EID cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K811582 · Cavitron Corp. · Dental device
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Jul 1981
Decision
53d
Days
Class 1
Risk

K811582 is an FDA 510(k) clearance for the THE PLACER. Classified as Syringe, Restorative And Impression Material (product code EID), Class I - General Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 53 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.

View all Cavitron Corp. devices

FDA 510(k) Submission Details - K811582

510(k) Number K811582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1981
Decision Date July 28, 1981
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
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 K811582.
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
APPLICATOR, LEE IMPRESSION
K781977 · Lee Pharmaceuticals · Dec 1978
APPLIC SYSTEM APPLIER, ESPE
K770931 · Espe GmbH (Us) · Jun 1977
APPLIC SYSTEM ACTIVATOR, ESPE
K770941 · Espe GmbH (Us) · Jun 1977