Cleared Traditional

CENTRIX PCR MOLAR MATRIX FORMS (BANDS)

K861581 · Centrix, Inc. · Dental
May 1986
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K861581 is an FDA 510(k) clearance for the CENTRIX PCR MOLAR MATRIX FORMS (BANDS), a Instruments, Dental Hand (Class I — General Controls, product code DZN), submitted by Centrix, Inc. (Stratford, US). The FDA issued a Cleared decision on May 12, 1986, 13 days after receiving the submission on April 29, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K861581 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1986
Decision Date May 12, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZN — Instruments, Dental Hand
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565