Cleared Traditional

K020062 - XERAFIT

K020062 is an FDA 510(k) clearance for XERAFIT, manufactured by Metalor Technologies USA. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K020062 · Metalor Technologies USA · Dental device
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Feb 2002
Decision
37d
Days
Class 2
Risk

K020062 is an FDA 510(k) clearance for the XERAFIT. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Metalor Technologies USA (North Attleborough, US). The FDA issued a Cleared decision on February 14, 2002 after a review of 37 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.

View all Metalor Technologies USA devices

FDA 510(k) Submission Details - K020062

510(k) Number K020062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2002
Decision Date February 14, 2002
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 127d · This submission: 37d
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 100
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K020062.
4 ALL (DW286A)
K020253 · Ivoclar Vivadent, Inc. · Apr 2002
D.SIGN 15 (DW286 B)
K020898 · Ivoclar Vivadent, Inc. · Mar 2002
PISCES PLUS (DW286 C)
K020183 · Ivoclar Vivadent, Inc. · Mar 2002
D.SIGN 30
K010381 · Ivoclar North America, Inc. · Mar 2001
AUROFILM NP
K003387 · Metalor Dental USA Corp. · Jan 2001
JEWEL CAST III
K003037 · Jeneric/Pentron, Inc. · Dec 2000