Cleared Traditional

K060946 - CZ-S2000

K060946 is the FDA 510(k) clearance for CZ-S2000 by Parkell, Inc.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K060946 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
70d
Days
Class 2
Risk

K060946 is an FDA 510(k) clearance for the CZ-S2000. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on June 15, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Parkell, Inc. devices

Submission Details

510(k) Number K060946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2006
Decision Date June 15, 2006
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 74
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K060946.
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004
DIAPEX
K033585 · Bisco, Inc. · Jan 2004
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc. · Aug 2001