Cleared Traditional

K861581 - CENTRIX PCR MOLAR MATRIX FORMS (BANDS)

K861581 is an FDA 510(k) clearance for CENTRIX PCR MOLAR MATRIX FORMS (BANDS), manufactured by Centrix, Inc.. The device is a Class 1 Dental device with product code DZN cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K861581 · Centrix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
13d
Days
Class 1
Risk

K861581 is an FDA 510(k) clearance for the CENTRIX PCR MOLAR MATRIX FORMS (BANDS). Classified as Instruments, Dental Hand (product code DZN), Class I - General Controls.

Submitted by Centrix, Inc. (Stratford, US). The FDA issued a Cleared decision on May 12, 1986 after a review of 13 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 - K861581

510(k) Number K861581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 12, 1986
Days to Decision 13 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
115d faster than avg
Panel avg: 128d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

DZN Device Classification - Class 1, General Controls

Product Code DZN Instruments, Dental Hand
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 - DZN Instruments, Dental Hand

All 15
Devices cleared under the same product code (DZN) and FDA review panel - the closest regulatory comparables to K861581.
COMPOTHIXO
K111465 · Kerrhawe SA · Jul 2012
DENTAL MATRIX BAND
K071858 · Fly Cast Technologies, Inc. · Aug 2007
CONTACT MOLAR BANDS AND CONTOUR STRIPS
K901919 · Ivoclar North America, Inc. · Jun 1990
TIGER BAND
K844324 · World Wide Outdoor Marketing · Dec 1984
INTERDENTAL WEDGES
K840984 · Healthco, Inc. · Apr 1984
DENTAL MATRIX BAND
K822094 · Dentsply Intl. · Aug 1982
K861581 · CENTRIX PCR MOLAR MATRIX FORMS (BANDS)
Download PDF Centrix, Inc.