Cleared Traditional

K062345 - CERAMIC BOND

K062345 is an FDA 510(k) clearance for CERAMIC BOND, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K062345 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
126d
Days
Class 2
Risk

K062345 is an FDA 510(k) clearance for the CERAMIC BOND. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on December 15, 2006 after a review of 126 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

FDA 510(k) Submission Details - K062345

510(k) Number K062345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2006
Decision Date December 15, 2006
Days to Decision 126 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
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K062345.
CLEARFIL MAJESTY ESTHETIC PLT
K070325 · Kuraray Medical, Inc. · Mar 2007
GRADIA DIRECT X
K070190 · GC America, Inc. · Mar 2007
TWINKY STAR NF
K063604 · Voco GmbH · Jan 2007
CELERITY
K062518 · Parkell, Inc. · Dec 2006
K-ETCHANT GEL
K062409 · Kuraray Medical, Inc. · Nov 2006
GRANDIO FLOW TRY-IN
K062343 · Voco GmbH · Nov 2006