Cleared Abbreviated

K022797 - TWINKY STAR

K022797 is an FDA 510(k) clearance for TWINKY STAR, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 48-day FDA review.

K022797 · Voco GmbH · Dental device
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Oct 2002
Decision
48d
Days
Class 2
Risk

K022797 is an FDA 510(k) clearance for the TWINKY STAR. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Voco GmbH (Bend, US). The FDA issued a Cleared decision on October 10, 2002 after a review of 48 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K022797

510(k) Number K022797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2002
Decision Date October 10, 2002
Days to Decision 48 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 128d · This submission: 48d
Pathway characteristics
Standards-based clearance path.

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 931
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K022797.
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K020760 · Danville Materials, Inc. · May 2002
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K020555 · Pentron Laboratory Technologies · Apr 2002
K022797 · TWINKY STAR
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