Cleared Traditional

K982459 - TEMPFIL F - 2

K982459 is the FDA 510(k) clearance for TEMPFIL F - 2 by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K982459 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
77d
Days
Class 2
Risk

K982459 is an FDA 510(k) clearance for the TEMPFIL F - 2. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 77 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K982459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date September 30, 1998
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 89
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K982459.
3M QUIK TEMP TEMPORIZATION MATERIAL
K001114 · 3M Company · Jun 2000
JELTEMP
K991564 · J.F. Jelenko & Co., Inc. · Jun 1999
SMARTEMP
K991270 · Parkell, Inc. · May 1999
3M QUIKPLUS SYSTEM
K970168 · 3M Company · Feb 1997
TEMPFIL C&B
K964981 · Sybron Dental Specialties, Inc. · Feb 1997
TEMPFIL F
K963786 · Sybron Dental Specialties, Inc. · Nov 1996