Skip to content

P10 Special

by North American Alloys, Inc.

510(k) K993344

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993344 Date15 Nov 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EJH
Device Class
Class II
Regulation
21 CFR Part 872.3710
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The P10 Special is a cobalt-based crown and bridge alloy containing chromium and molybdenum. It is classified as a base metal alloy intended for the fabrication of custom crown or bridge prostheses by a dental laboratory.

This device is subject to FDA 510(k) clearance under K993344. It is regulated under 21 CFR 872.3710 and is categorized under product code EJH for dental applications.

Other devices from North American Alloys, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the P10 Special alloy used for?

    The P10 Special is a base metal alloy specifically intended for use by dental laboratories to fabricate custom crown or bridge prostheses.

  • What is the chemical composition of this alloy?

    The P10 Special is a cobalt-based alloy that also contains chromium and molybdenum as part of its formulation for dental applications.

  • Is this device subject to regulatory oversight?

    Yes, the P10 Special is subject to FDA 510(k) clearance under K993344 and is regulated under 21 CFR 872.3710, categorized under product code EJH.