Cleared Traditional

K012360 - LC TEMPORARY FILLING

K012360 is an FDA 510(k) clearance for LC TEMPORARY FILLING, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K012360 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
43d
Days
Class 2
Risk

K012360 is an FDA 510(k) clearance for the LC TEMPORARY FILLING. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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

FDA 510(k) Submission Details - K012360

510(k) Number K012360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2001
Decision Date September 06, 2001
Days to Decision 43 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
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 150
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K012360.
TEMPHASE
K020092 · Kerr Dental Materials Center · Feb 2002
TEMPFIL
K013895 · Sybron Dental Specialties, Inc. · Feb 2002
LUXATEMP/LUXATEMP SOLAR/INSTATEMP
K013674 · Dmg USA, Inc. · Jan 2002
LC PROVIFILL
K010012 · S & C Polymer GmbH · Feb 2001
PATTERN RESIN
K003817 · GC America, Inc. · Jan 2001
FERMIT PLUS
K003374 · Ivoclar North America, Inc. · Dec 2000