Cleared Traditional

K050604 - KERR VPS IMPRESSION MATERIAL

K050604 is the FDA 510(k) clearance for KERR VPS IMPRESSION MATERIAL by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K050604 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
37d
Days
Class 2
Risk

K050604 is an FDA 510(k) clearance for the KERR VPS IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on April 15, 2005 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 K050604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2005
Decision Date April 15, 2005
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 124
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K050604.
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · Dentsply Intl. · Jun 2006
EXPASYL POWER APPLICATOR
K051933 · Sybron Dental Specialties, Inc. · Jan 2006
MODIFICATION TO:REGISTRADO X-TRA
K051535 · Voco GmbH · Jun 2005
FUSION PUTTY TYPE
K043493 · GC America, Inc. · Mar 2005
FUSION FAST
K043471 · GC America, Inc. · Jan 2005
FLEXITIME XTREME
K042878 · Heraeus Kulzer, Inc. · Dec 2004