Cleared Traditional

VONFLEX PUTTY (K091267) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091267 · Vericom Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
6d
Days
Class 2
Risk

K091267 is an FDA 510(k) clearance for the VONFLEX PUTTY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on May 6, 2009 after a review of 6 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 Vericom Co., Ltd. devices

Submission Details

510(k) Number K091267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2009
Decision Date May 06, 2009
Days to Decision 6 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 127d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 85
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K091267.
FIT CHECKER ADVANCED
K110871 · GC America, Inc. · Jun 2011
FIT TEST C&B
K110050 · Voco GmbH · Mar 2011
FLEXITIME FLOW
K091494 · Heraeus Kulzer, Inc. · Jul 2009
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · Dentsply Intl. · Jun 2006
MODIFICATION TO:REGISTRADO X-TRA
K051535 · Voco GmbH · Jun 2005
FUSION PUTTY TYPE
K043493 · GC America, Inc. · Mar 2005