Cleared Traditional

K974465 - SYNERGY

K974465 is an FDA 510(k) clearance for SYNERGY, manufactured by Coltene/Whaledent, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K974465 · Coltene/Whaledent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
103d
Days
Class 2
Risk

K974465 is an FDA 510(k) clearance for the SYNERGY. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on March 9, 1998 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Coltene/Whaledent, Inc. devices

FDA 510(k) Submission Details - K974465

510(k) Number K974465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1997
Decision Date March 09, 1998
Days to Decision 103 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
24d faster than avg
Panel avg: 127d · This submission: 103d
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 670
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K974465.
PRODIGY 2
K982148 · Sybron Dental Specialties, Inc. · Jul 1998
PALFIQUE ESTELITE
K980054 · Tokuyama America, Inc. · Apr 1998
TOKUSO MAC BOND II
K980058 · Tokuyama America, Inc. · Apr 1998
PALFIQUE ESTELITE PASTE
K980051 · Tokuyama America, Inc. · Feb 1998
COMPOSITE 168 RESTORATIVE SYSTEM
K973221 · Dentsply Intl. · Feb 1998
NTL-FLOW
K974483 · Bisco, Inc. · Feb 1998