Cleared Traditional

K060637 - DENFIL FLOW

K060637 is an FDA 510(k) clearance for DENFIL FLOW, manufactured by Vericom Co., Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K060637 · Vericom Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
6d
Days
Class 2
Risk

K060637 is an FDA 510(k) clearance for the DENFIL FLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 16, 2006 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Vericom Co., Ltd. devices

FDA 510(k) Submission Details - K060637

510(k) Number K060637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2006
Decision Date March 16, 2006
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 128d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Bsi Healthcare
JOHN HOWLETT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 836
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