Cleared Traditional

K032136 - WIROBOND C

K032136 is an FDA 510(k) clearance for WIROBOND C, manufactured by Bego U.S.A.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K032136 · Bego U.S.A. · Dental device
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Sep 2003
Decision
55d
Days
Class 2
Risk

K032136 is an FDA 510(k) clearance for the WIROBOND C. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Bego U.S.A. (Lincoln, US). The FDA issued a Cleared decision on September 4, 2003 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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.

FDA 510(k) Submission Details - K032136

510(k) Number K032136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2003
Decision Date September 04, 2003
Days to Decision 55 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
73d faster than avg
Panel avg: 128d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 142
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K032136.
CONTINUM
K040179 · Aalba Dent, Inc. · Mar 2004
VERASOFT ES
K033356 · Aalba Dent, Inc. · Dec 2003
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
K033045 · American Green Dent. Mfg, Inc. · Dec 2003
NANO-TICROWN
K031627 · Nano-Write Corp. · Jun 2003
PD CASTA-H
K030632 · Mountain Medico, Inc. · May 2003
CERACAST-V
K030416 · Mountain Medico, Inc. · Apr 2003
K032136 · WIROBOND C
Download PDF Bego U.S.A.