Cleared Traditional

K993344 - P10 SPECIAL

K993344 is an FDA 510(k) clearance for P10 SPECIAL, 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 41-day FDA review.

K993344 · North American Alloys, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
41d
Days
Class 2
Risk

K993344 is an FDA 510(k) clearance for the P10 SPECIAL. 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 November 15, 1999 after a review of 41 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 - K993344

510(k) Number K993344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1999
Decision Date November 15, 1999
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 127d · This submission: 41d
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 97
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K993344.
GOLD CORE II
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K992881 · Matech, Inc. · Nov 1999
CERADIUM NON-PRECIOUS CERAMIC ALLOY
K992705 · Matech, Inc. · Sep 1999
D-SIGN V (R&D PROJECT DW267#17)
K990182 · Ivoclar North America, Inc. · Mar 1999
D-SIGN VI (R&D PROJECT DW266#9)
K990235 · Ivoclar North America, Inc. · Mar 1999