Cleared Traditional

OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR

K971063 · King Dental Corp. · Dental
Jun 1997
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K971063 is an FDA 510(k) clearance for the OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR, a Chair, Dental, With Operative Unit (Class I — General Controls, product code KLC), submitted by King Dental Corp. (Miami, US). The FDA issued a Cleared decision on June 3, 1997, 71 days after receiving the submission on March 24, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K971063 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1997
Decision Date June 03, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLC — Chair, Dental, With Operative Unit
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6250