Cleared Traditional

K011666 - CHILLIT

K011666 is an FDA 510(k) clearance for CHILLIT, manufactured by Heatshield, Inc.. The device is a Class 2 Dental device with product code EAT cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K011666 · Heatshield, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
68d
Days
Class 2
Risk

K011666 is an FDA 510(k) clearance for the CHILLIT. Classified as Tester, Pulp (product code EAT), Class II - Special Controls.

Submitted by Heatshield, Inc. (New Rochelle, US). The FDA issued a Cleared decision on August 6, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1720 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heatshield, Inc. devices

FDA 510(k) Submission Details - K011666

510(k) Number K011666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAT Device Classification - Class 2, Special Controls

Product Code EAT Tester, Pulp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EAT Tester, Pulp

All 11
Devices cleared under the same product code (EAT) and FDA review panel - the closest regulatory comparables to K011666.
THERMIQUE
K022097 · Parkell, Inc. · Sep 2002
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
K012427 · Specialites Septodont · Oct 2001
ENDO ANALYZER, MODEL 8005, MODIFIED
K990225 · Sybron Dental Specialties, Inc. · Feb 1999
ENDO ANALYZER, MODEL 8005
K973439 · Sybron Dental Specialties, Inc. · Dec 1997
SYSTEM B HEAT SOURCE
K970715 · Sybron Dental Specialties, Inc. · Apr 1997
TOUCH N' HEAT
K963862 · Sybron Dental Specialties, Inc. · Dec 1996