Cleared Traditional

RUBBER DAM CLAMPS/FORCEPS

K892261 · Zinnanti Surgical Instruments, Inc. · Dental
May 1989
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K892261 is an FDA 510(k) clearance for the RUBBER DAM CLAMPS/FORCEPS, a Burnisher, Operative (Class I — General Controls, product code EKJ), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 10, 1989, 36 days after receiving the submission on April 4, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K892261 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1989
Decision Date May 10, 1989
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EKJ — Burnisher, Operative
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565