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3I Titanium Plasma Sprayed Standard Threaded & Self-Tapping Implants

by Implant Innovations, Inc. 510(k)

Active United States

510(k) K955427

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955427 Date9 Feb 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

This device is a dental implant made of titanium with a plasma-sprayed surface, featuring standard threaded and self-tapping design. It is intended for use in dental applications as indicated by the advisory committee classification.

The implant is supplied as a reusable or single-use device (specific use not stated in data) and is authorized under FDA 510(k) clearance K955427. It is manufactured by Implant Innovations, Inc. and classified under product code DZE with advisory committee designation DE (Dental).

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Questions

AI-generated answers, 23 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 3I Titanium Plasma Sprayed Standard Threaded & Self-Tapping Implant used for?

    This device is a dental implant intended for use in dental applications, as indicated by its advisory committee classification DE (Dental), and is designed for placement in the jawbone to support prosthetic teeth.

  • How is the 3I Titanium Plasma Sprayed Standard Threaded & Self-Tapping Implant supplied?

    The implant is supplied as either a reusable or single-use device, though the specific use mode is not stated in the provided data; users should refer to labeling for definitive instructions on reuse or disposal.

  • What regulatory authorization does the 3I Titanium Plasma Sprayed Standard Threaded & Self-Tapping Implant have?

    The device is authorized under FDA 510(k) clearance K955427, classified under product code DZE with advisory committee designation DE (Dental), and was found substantially equivalent to a predicate device in a traditional 510(k) review.