Cleared Traditional

K974105 - KERR COMPOMER

K974105 is an FDA 510(k) clearance for KERR COMPOMER, 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 70-day FDA review.

K974105 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
70d
Days
Class 2
Risk

K974105 is an FDA 510(k) clearance for the KERR COMPOMER. 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 January 9, 1998 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K974105

510(k) Number K974105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1997
Decision Date January 09, 1998
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.

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 760
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K974105.
PERMAFLO
K974413 · Ultradent Products, Inc. · Feb 1998
COMPOGLASS FLOW
K974577 · Ivoclar North America, Inc. · Jan 1998
VITALESCENCE
K974282 · Ultradent Products, Inc. · Jan 1998
SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
K973513 · Espe GmbH & Co. Kg. · Dec 1997
ALERT
K974131 · Jeneric/Pentron, Inc. · Dec 1997
FREEDOM
K973089 · Southern Dental Industries, Inc. · Dec 1997