Cleared Traditional

DENTAL MATRIX BAND

K822094 · Dentsply Intl. · Dental
Aug 1982
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K822094 is an FDA 510(k) clearance for the DENTAL MATRIX BAND, a Instruments, Dental Hand (Class I — General Controls, product code DZN), submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982, 31 days after receiving the submission on July 16, 1982. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K822094 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1982
Decision Date August 16, 1982
Days to Decision 31 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