Cleared Traditional

ULTIMA 2 DENTAL CHAIR

K942870 · Dentech Corp. · Dental

Feb 1995

Decision

255d

Days

Class 1

Risk

About This 510(k) Submission

K942870 is an FDA 510(k) clearance for the ULTIMA 2 DENTAL CHAIR, a Chair, Dental, With Operative Unit (Class I — General Controls, product code KLC), submitted by Dentech Corp. (Sumas, US). The FDA issued a Cleared decision on February 27, 1995, 255 days after receiving the submission on June 17, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number	K942870 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 1994
Decision Date	February 27, 1995
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement