Cleared Traditional

K003387 - AUROFILM NP

K003387 is an FDA 510(k) clearance for AUROFILM NP, manufactured by Metalor Dental USA Corp.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K003387 · Metalor Dental USA Corp. · Dental device
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Jan 2001
Decision
70d
Days
Class 2
Risk

K003387 is an FDA 510(k) clearance for the AUROFILM NP. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on January 9, 2001 after a review of 70 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 Dental USA Corp. devices

FDA 510(k) Submission Details - K003387

510(k) Number K003387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2000
Decision Date January 09, 2001
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
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 99
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K003387.
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
JEWEL CAST III
K003037 · Jeneric/Pentron, Inc. · Dec 2000
GOLD CORE II
K003039 · Jeneric/Pentron, Inc. · Dec 2000
CERADIUM V NON-PRECIOUS CERAMIC ALLOY
K993572 · Matech, Inc. · Dec 1999