Cleared Traditional

K011798 - CORERESTORE 2

K011798 is an FDA 510(k) clearance for CORERESTORE 2, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K011798 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
67d
Days
Class 2
Risk

K011798 is an FDA 510(k) clearance for the CORERESTORE 2. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on August 14, 2001 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Sybron Dental Specialties, Inc. devices

FDA 510(k) Submission Details - K011798

510(k) Number K011798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2001
Decision Date August 14, 2001
Days to Decision 67 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
60d faster than avg
Panel avg: 127d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 761
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K011798.
A-WEAR
K012180 · Bisco, Inc. · Sep 2001
POINT 4 FLOWABLE
K012321 · Sybron Dental Specialties, Inc. · Aug 2001
LUXACORE/LUXACORE DUAL
K012307 · Dmg USA, Inc. · Aug 2001
ADMIRA FLOW
K011756 · Voco GmbH · Jul 2001
IN TEN-S
K011492 · Ivoclar North America, Inc. · Jul 2001
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
K011211 · Dmg USA, Inc. · Jun 2001