Cleared Traditional

Visalys® Bulk Fill 1 x 4 g Syringe (15060) (K250267) - FDA 510(k) Clearance

Also marketed or referenced as:
Visalys® Bulk Fill 15 x 0.25 g Caps (15062) Visalys® Bulk Flow 1 x 2 g Syringe (15064) Visalys® Bulk Flow 15 x 0.25 g Caps (15066) Visalys® Bulk Flow Intro pack (15067) Visalys® Bulk Intro pack (15068)

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

K250267 · Kettenbach GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
43d
Days
Class 2
Risk

K250267 is an FDA 510(k) clearance for the Visalys® Bulk Fill 1 x 4 g Syringe (15060). Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on March 14, 2025 after a review of 43 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 Kettenbach GmbH & Co. KG devices

Submission Details

510(k) Number K250267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2025
Decision Date March 14, 2025
Days to Decision 43 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
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 291
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