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INZOMA P

by J. Aderer, Inc. 510(k)

Active United States

510(k) K813417

Overview

The INZOMA P is a Class 2 dental device, specifically an alloy of gold-based noble metal. It is designed for use within the dental specialty.

This device was authorized via FDA 510(k) clearance K813417, which was granted on January 7, 1982, following a traditional clearance pathway. It is manufactured by J. Aderer, Inc.

AI-generated from registry data, 5 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813417 Date7 Jan 1982ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EJT
Device Class
Class II
Regulation
21 CFR Part 872.3060
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from J. Aderer, Inc.

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    Class II

  • Sr-Ivotray Special

    Class I

  • Bond-On

    Class II

  • 82 Alloy

    Class II

See all devices from J. Aderer, Inc. →

Questions

  • What is the INZOMA P device?

    The INZOMA P is a gold-based noble metal alloy, which is a type of material used in dentistry. It is specifically categorized as a Class 2 dental device.

  • What is the intended use of the INZOMA P?

    The INZOMA P is intended for use within the dental specialty. As a gold-based noble metal alloy, it is typically used for dental restorations and other applications where such materials are required.

  • What is the regulatory status of the INZOMA P?

    The INZOMA P was authorized for use through FDA 510(k) clearance K813417. This clearance was granted on January 7, 1982, following a traditional clearance pathway.