Cleared Traditional

K853498 - PERFECT 10

K853498 is an FDA 510(k) clearance for PERFECT 10, manufactured by North American Alloys, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K853498 · North American Alloys, Inc. · Dental device
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Sep 1985
Decision
38d
Days
Class 2
Risk

K853498 is an FDA 510(k) clearance for the PERFECT 10. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by North American Alloys, Inc. (Bloomingdale, US). The FDA issued a Cleared decision on September 27, 1985 after a review of 38 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 North American Alloys, Inc. devices

FDA 510(k) Submission Details - K853498

510(k) Number K853498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date September 27, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 127d · This submission: 38d
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 98
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K853498.
H40 BASE METAL ALLOY
K854878 · Jeneric Ind. · Jan 1986
GDC 1453 CASTING ALLOY
K854285 · Deringer-Ney, Inc. · Dec 1985
CERAMIC ALLOY NO. DW 179
K852895 · Williams Gold Refining Co., Inc. · Oct 1985
VERA BOND NON PERCIOUS CERAMIC ALLOY
K851569 · Aalba Dent, Inc. · May 1985
AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY
K844497 · Austenal Dental, Inc. · Feb 1985
RX CBG
K844122 · Jeneric Ind. · Jan 1985