Cleared Traditional

K010012 - LC PROVIFILL

K010012 is an FDA 510(k) clearance for LC PROVIFILL, manufactured by S & C Polymer GmbH. 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.

K010012 · S & C Polymer GmbH · Dental device
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Feb 2001
Decision
43d
Days
Class 2
Risk

K010012 is an FDA 510(k) clearance for the LC PROVIFILL. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by S & C Polymer GmbH (Elmshorn, DE). The FDA issued a Cleared decision on February 14, 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 S & C Polymer GmbH devices

FDA 510(k) Submission Details - K010012

510(k) Number K010012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2001
Decision Date February 14, 2001
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
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 116
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K010012.
TEMPFIL
K013895 · Sybron Dental Specialties, Inc. · Feb 2002
LUXATEMP/LUXATEMP SOLAR/INSTATEMP
K013674 · Dmg USA, Inc. · Jan 2002
LC TEMPORARY FILLING
K012360 · Parkell, Inc. · Sep 2001
PATTERN RESIN
K003817 · GC America, Inc. · Jan 2001
FERMIT PLUS
K003374 · Ivoclar North America, Inc. · Dec 2000
FERMIT N PLUS
K003377 · Ivoclar North America, Inc. · Dec 2000