Cleared Traditional

PALATRAY LC MINT

K930487 · Heraeus Kulzer, Inc. · Dental

Jun 1993

Decision

140d

Days

Class 1

Risk

About This 510(k) Submission

K930487 is an FDA 510(k) clearance for the PALATRAY LC MINT, a Material, Impression Tray, Resin (Class I — General Controls, product code EBH), submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on June 18, 1993, 140 days after receiving the submission on January 29, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.3670.

Submission Details

510(k) Number	K930487 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 1993
Decision Date	June 18, 1993
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement