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P.004 Abutments

by Straumann USA (On Behalf of Institut Straumann Ag)

510(k) K071919

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 NumberK071919 Date26 Sep 2007ClearedStatusActive

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  • Withdrawn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
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The P.004 Abutments are a dental device, part of an integrated system of endosseous dental implants, designed to support prosthetic devices. They are substantially equivalent and classified under the product code NHA. The device is used in dental applications.

The P.004 Abutments are supplied by Straumann USA on behalf of Institut Straumann Ag. They have been cleared under the FDA 510K traditional clearance type, with the decision code SESE. The device is associated with the k number K071919 and is intended for use in dental settings.

Other devices from Straumann USA, LLC (On Behalf of Institut Straumann Ag)

Questions

AI-generated answers, 1 Oct 2026

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

  • What are the P.004 Abutments used for?

    The P.004 Abutments are used to support prosthetic devices in dental applications, as part of an integrated system of endosseous dental implants.

  • How are the P.004 Abutments supplied?

    The P.004 Abutments are supplied by Straumann USA on behalf of Institut Straumann Ag.

  • What is the regulatory clearance type for the P.004 Abutments?

    The P.004 Abutments have been cleared under the FDA 510K traditional clearance type, with the decision code SESE and k number K071919.