Cleared Traditional

K926418 - CLIP

K926418 is the FDA 510(k) clearance for CLIP by Voco GmbH. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K926418 · Voco GmbH · Dental device
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Mar 1993
Decision
98d
Days
Class 2
Risk

K926418 is an FDA 510(k) clearance for the CLIP. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Voco GmbH devices

Submission Details

510(k) Number K926418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date March 31, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
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 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K926418.
VARIOLINK
K931309 · Ivoclar North America, Inc. · Jul 1993
CHARISMA -- MODIFIED
K932013 · Heraeus Kulzer, Inc. · Jul 1993
VIVALUX
K926556 · Ivoclar North America, Inc. · Apr 1993
PULPDENT DENTAL BOND ENCHANCER
K926074 · Pulpdent Corp. · Mar 1993
BISCO D/C RESINOMER
K924151 · Bisco, Inc. · Dec 1992
TRIAD INLAY COMPOSITE
K923236 · Dentsply Intl. · Sep 1992