Cleared Traditional

CHILLIT

K011666 · Heatshield, Inc. · Dental

Aug 2001

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K011666 is an FDA 510(k) clearance for the CHILLIT, a Tester, Pulp (Class II — Special Controls, product code EAT), submitted by Heatshield, Inc. (New Rochelle, US). The FDA issued a Cleared decision on August 6, 2001, 68 days after receiving the submission on May 30, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number	K011666 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2001
Decision Date	August 06, 2001
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement